Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03086265
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether laser laryngeal surgery can be safely and potentially more effectively performed without the use of tracheal intubation or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannula: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).

Condition or Disease	Intervention/Treatment	Phase
Otorhinolaryngologic Surgical Procedures; Laser Therapy	Device: THRIVE; Device: Endotracheal tube	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Laser Laryngeal Surgery
• Actual Study Start Date: Mar 24, 2017
• Actual Primary Completion Date: Feb 26, 2019
• Actual Study Completion Date: Feb 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: THRIVE high flow nasal oxygen	Device: THRIVE; active nasal oxygen delivery system
Active Comparator: Endotracheal tube tracheal intubation	Device: Endotracheal tube; Plastic tube for supporting ventilation during surgery

Outcome Measures

Primary Outcome Measures

1. Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) [Duration of surgery (average approximately 1 hour)]

   Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.

2. Partial Pressure of Oxygen in the Arterial Blood (PaO2) [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)]

3. Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)]

4. pH in Blood [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)]

   The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base.

5. Heart Rate [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)]

6. Mean Arterial Pressure (MAP) [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)]

7. Stroke Volume Index (SVI) [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)]

   Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).

8. Cardiac Index (CI) [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)]

   Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.

9. Systemic Vascular Resistance Index (SVRI) [Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)]

   SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).

10. Awakening/Extubation Time [Duration of surgery (average approximately 1 hour)]

    Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.

11. Time to Suspension [Duration of surgery (average approximately 1 hour)]

    Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.

12. Number of Suspension Adjustments [Duration of surgery (average approximately 1 hour)]

    Number of adjustments of the suspension laryngoscope.

13. Duration of Surgery [Duration of surgery (average approximately 1 hour)]

    Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.

Secondary Outcome Measures

1. Count of Participants Requiring Jet Ventilation [Duration of surgery (average approximately 1 hour)]

   Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.

2. Time to Spontaneous Ventilation [Duration of surgery (average approximately 1 hour)]

   Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.

3. Apnea Time [Duration of surgery (average approximately 1 hour)]

   Recorded from induction of anesthesia to the return of spontaneous ventilation.

4. Duration of Anesthesia [Duration of surgery (average approximately 1 hour)]

   Recorded from induction of anesthesia to patient's awakening/extubation

5. Total Propofol Dose (Anesthetic) [Duration of surgery (average approximately 1 hour)]

6. Total Remifentanil Dose (Anesthetic) [Duration of surgery (average approximately 1 hour)]

7. Total Phenylephrine Dose (Vasoactive Drug) [Duration of surgery (average approximately 1 hour)]

8. Total Ephedrine Dose (Vasoactive Drug) [Duration of surgery (average approximately 1 hour)]

9. Total Labetalol Dose (Vasoactive Drug) [Duration of surgery (average approximately 1 hour)]

10. Time to Patient Being Alert and Oriented x 4 [Duration of surgery (average approximately 1 hour)]

    Recorded from patient's admission to the recovery room to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.

11. Recovery Room Discharge-ready Time [Duration of recovery room stay (average approximately 1 hour)]

    From admission to recovery room, to discharge from recovery room

12. First Pain Score in Recovery Room [Duration of recovery room stay (average approximately 1 hour)]

    Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).

13. Pain Score at Discharge From Recovery Room [Duration of recovery room stay (average approximately 1 hour)]

    Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).

14. Analgesic Consumption [Recovery room to 7th postoperative day]

    Analgesic consumption was measured in oral morphine milligram equivalents (MME)

15. Quality of Recovery (QoR)15 Score [Prior to procedure, and 1-2 hours after procedure]

    The QoR15 has 15 questions each is on a scale of 0-10 to measure patient functionality. Scores are summed for an overall range of 0-150, with higher scores corresponding to better recovery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients presenting for laser laryngeal surgery

Exclusion Criteria:

1. Patients with significantly decreased myocardial function (ejection fraction < 50%)

2. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.

3. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.

4. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs) .

5. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2.

6. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.

7. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).

8. Patients with skull base defects.

9. Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.

10. Patients with significant chronic obstructive or restrictive lung diseases, as manifested by known history of baseline chronic hypoxia and/or hypercapnia, and/or baseline room air oxygen saturation (SpO2) < 95% .

11. Obese patients with BMI > 35 kg/m2.

12. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.

13. Patients with hiatal hernia and full stomach patients.

14. Patient's refusal to participate in the study.

15. Patients who do not understand English or mentally handicapped. Pregnant or breastfeeding patients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Hospital and Clinics	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Vladimir Nekhendzy, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol - Aug 12, 2016
• Statistical Analysis Plan - Feb 24, 2020

More Information

Publications

None provided.

• Responsible Party: Vladimir Nekhendzy, Clinical Professor of Anesthesiology and Otolaryngology, Stanford University
• ClinicalTrials.gov Identifier: NCT03086265
• Other Study ID Numbers: 36060
• First Posted: Mar 22, 2017
• Last Update Posted: Mar 17, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Vladimir Nekhendzy, Clinical Professor of Anesthesiology and Otolaryngology, Stanford University: airway management; high flow nasal oxygen high flow nasal cannula THRIVE; high flow nasal cannula THRIVE; THRIVE

Study Results

Participant Flow

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	THRIVE	Endotracheal Tube	Total
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (15)	52 (12)	53 (13)
Sex: Female, Male (Count of Participants)
Female	8 80%	6 60%	14 70%
Male	2 20%	4 40%	6 30%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
Description	Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [percentage of oxygen]	97 (2)	97 (3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7934
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Partial Pressure of Oxygen in the Arterial Blood (PaO2)
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Measure Participants	10
Induction	365 (40)
10 minutes post-induction	294 (79)
20 minutes post-induction	279 (81)
30 minutes post-induction	245 (81)
40 minutes post-induction	223 (67)
Spontaneous ventilation	251 (102)
Recovery room	86 (13)

3. Primary Outcome

Title	Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Measure Participants	10
Induction	32 (5)
10 minutes post-induction	54 (5)
20 minutes post-induction	65 (9)
30 minutes post-induction	77 (8)
40 minutes post-induction	86 (7)
Spontaneous ventilation	71 (13)
Recovery room	37 (5)

4. Primary Outcome

Title	pH in Blood
Description	The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base.
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
Measure Participants	10
Induction	7.4 (0)
10 minutes post-induction	7.2 (0)
20 minutes post-induction	7.2 (0)
30 minutes post-induction	7.1 (0)
40 minutes post-induction	7.1 (0.1)
Spontaneous ventilation	7.4 (0.1)
Recovery room	7.4 (0)

5. Primary Outcome

Title	Heart Rate
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Induction	65 (11)	70 (15)
10 minutes post-induction	72 (12)	81 (14)
20 minutes post-induction	79 (13)	79 (9)
30 minutes post-induction	79 (14)	76 (12)
40 minutes post-induction	81 (15)	73 (9)
Spontaneous ventilation	72 (14)	71 (15)

6. Primary Outcome

Title	Mean Arterial Pressure (MAP)
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Induction	90 (16)	92 (12)
10 minutes post-induction	78 (12)	76 (9)
20 minutes post-induction	71 (9)	83 (17)
30 minutes post-induction	72 (12)	85 (13)
40 minutes post-induction	69 (13)	80 (12)
Spontaneous ventilation	88 (14)	88 (18)

7. Primary Outcome

Title	Stroke Volume Index (SVI)
Description	Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Induction	50 (10)	48 (13)
10 minutes post-induction	45 (7)	36 (7)
20 minutes post-induction	48 (10)	35 (6)
30 minutes post-induction	51 (12)	39 (9)
40 minutes post-induction	52 (6)	43 (10)
Spontaneous ventilation	54 (17)	53 (12)

8. Primary Outcome

Title	Cardiac Index (CI)
Description	Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Induction	3.2 (0.7)	3.4 (0.9)
10 minutes post-induction	3.2 (0.7)	3.0 (0.7)
20 minutes post-induction	3.7 (0.5)	2.8 (0.5)
30 minutes post-induction	3.9 (0.7)	3.0 (0.6)
40 minutes post-induction	4.2 (0.8)	3.1 (0.7)
Spontaneous ventilation	3.7 (0.9)	3.6 (0.6)

9. Primary Outcome

Title	Systemic Vascular Resistance Index (SVRI)
Description	SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).
Time Frame	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants with measurements at each respective time point are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Induction	2249 (652)	2140 (443)
10 minutes post-induction	1769 (549)	2026 (446)
20 minutes post-induction	1341 (321)	2182 (440)
30 minutes post-induction	1330 (464)	2080 (446)
40 minutes post-induction	1130 (217)	1187 (530)
Spontaneous ventilation	1841 (443)	2152 (578)

10. Primary Outcome

Title	Awakening/Extubation Time
Description	Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	14 (3)	13 (6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6876
	Comments
	Method	t-test, 2 sided
	Comments

11. Primary Outcome

Title	Time to Suspension
Description	Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	4 (2)	3 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7549
	Comments
	Method	t-test, 2 sided
	Comments

12. Primary Outcome

Title	Number of Suspension Adjustments
Description	Number of adjustments of the suspension laryngoscope.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [adjustments]	1 (1)	2 (4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6479
	Comments
	Method	t-test, 2 sided
	Comments

13. Primary Outcome

Title	Duration of Surgery
Description	Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	61 (29)	57 (44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8322
	Comments
	Method	t-test, 2 sided
	Comments

14. Secondary Outcome

Title	Count of Participants Requiring Jet Ventilation
Description	Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Count of Participants [Participants]	7 70%	0 0%

15. Secondary Outcome

Title	Time to Spontaneous Ventilation
Description	Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	5 (4)	11 (5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0058
	Comments
	Method	t-test, 2 sided
	Comments

16. Secondary Outcome

Title	Apnea Time
Description	Recorded from induction of anesthesia to the return of spontaneous ventilation.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	70 (28)	87 (48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3346
	Comments
	Method	t-test, 2 sided
	Comments

17. Secondary Outcome

Title	Duration of Anesthesia
Description	Recorded from induction of anesthesia to patient's awakening/extubation
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	78 (28)	89 (48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5513
	Comments
	Method	t-test, 2 sided
	Comments

18. Secondary Outcome

Title	Total Propofol Dose (Anesthetic)
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [mg]	730 (288)	920 (388)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1927
	Comments
	Method	t-test, 2 sided
	Comments

19. Secondary Outcome

Title	Total Remifentanil Dose (Anesthetic)
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [µg]	996 (674)	1114 (432)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6483
	Comments
	Method	t-test, 2 sided
	Comments

20. Secondary Outcome

Title	Total Phenylephrine Dose (Vasoactive Drug)
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants who received phenylephrine are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	6	4
Mean (Standard Deviation) [mg]	300 (591)	479 (757)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5625
	Comments
	Method	t-test, 2 sided
	Comments

21. Secondary Outcome

Title	Total Ephedrine Dose (Vasoactive Drug)
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants who received ephedrine are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	3	2
Mean (Standard Deviation) [mg]	4 (8)	1 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2827
	Comments
	Method	t-test, 2 sided
	Comments

22. Secondary Outcome

Title	Total Labetalol Dose (Vasoactive Drug)
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Participants who received labetalol are included in the analysis.

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	3	6
Mean (Standard Deviation) [mg]	15 (22)	13 (21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8426
	Comments
	Method	t-test, 2 sided
	Comments

23. Secondary Outcome

Title	Time to Patient Being Alert and Oriented x 4
Description	Recorded from patient's admission to the recovery room to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.
Time Frame	Duration of surgery (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	23 (29)	23 (19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9856
	Comments
	Method	t-test, 2 sided
	Comments

24. Secondary Outcome

Title	Recovery Room Discharge-ready Time
Description	From admission to recovery room, to discharge from recovery room
Time Frame	Duration of recovery room stay (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	64 (18)	62 (12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8112
	Comments
	Method	t-test, 2 sided
	Comments

25. Secondary Outcome

Title	First Pain Score in Recovery Room
Description	Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Time Frame	Duration of recovery room stay (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [score on a scale]	2 (4)	3 (3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6587
	Comments
	Method	t-test, 2 sided
	Comments

26. Secondary Outcome

Title	Pain Score at Discharge From Recovery Room
Description	Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Time Frame	Duration of recovery room stay (average approximately 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [score on a scale]	3 (2)	2 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4143
	Comments
	Method	t-test, 2 sided
	Comments

27. Secondary Outcome

Title	Analgesic Consumption
Description	Analgesic consumption was measured in oral morphine milligram equivalents (MME)
Time Frame	Recovery room to 7th postoperative day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Mean (Standard Deviation) [MME]	12 (17)	8 (7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4324
	Comments
	Method	t-test, 2 sided
	Comments

28. Secondary Outcome

Title	Quality of Recovery (QoR)15 Score
Description	The QoR15 has 15 questions each is on a scale of 0-10 to measure patient functionality. Scores are summed for an overall range of 0-150, with higher scores corresponding to better recovery.
Time Frame	Prior to procedure, and 1-2 hours after procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THRIVE	Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).	Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
Measure Participants	10	10
Preoperative	135 (17)	138 (8)
Postoperative	146 (5)	136 (11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments	Comparison of preoperative scores.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7221
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	THRIVE, Endotracheal Tube
	Comments	Comparison of postoperative scores.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0336
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Up to 1 week
Arm/Group Title	THRIVE		Endotracheal Tube
Arm/Group Description	Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).		Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
All Cause Mortality
	THRIVE		Endotracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	THRIVE		Endotracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	THRIVE		Endotracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.