Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03369197
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia; Endoscopy; Anesthesia Morbidity	Device: Nasal Mask; Device: Control: Nasal Cannula	N/A

Detailed Description

This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and degree of respiratory depression associated with hypoxia and hypoventilation by characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as the rate and degree of airway obstruction. The investigators hypothesize that the addition of nasal continuous positive airway pressure in the intervention arm will lead to decreased obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia will be monitored by Bispectral Index and investigators hypothesize that the degree of hypoventilation, obstruction, and will be significantly lower in the intervention arm compared to the control arm. Further, the depth of anesthesia will be independent of total propofol dose received. While the primary outcome in this study is hypoxia, investigators also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon dioxide measurement to better understand the total effects of sedation on respiration. Thus the study will also serve to evaluate which mode(s) of respiratory monitoring might be the best possible intervention to enhance safety during procedural sedation in the future. Further, investigators suspect that the amplitude of end tidal carbon dioxide will not predict the degree of respiratory depression seen with other monitors. In addition, investigators will measure serum short chain fatty acid concentrations as a predictor and possible mechanism for differences in individual variability in anesthesia induced respiratory depression.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of an Intervention to Reduce the Incidence of Hypoxia With Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
• Actual Study Start Date: Oct 30, 2017
• Actual Primary Completion Date: Oct 23, 2019
• Actual Study Completion Date: Oct 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention: Nasal Mask Nasal anesthesia mask with positive pressure	Device: Nasal Mask; Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve; Other Names: Intervention: Nasal anesthesia mask with positive pressure
Active Comparator: Control: Nasal cannula Nasal Cannula with standard care	Device: Control: Nasal Cannula; Nasal cannula as per usual care; Other Names: Standard Care

Outcome Measures

Primary Outcome Measures

1. Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event [Approximately 1 hour]

   Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.

Secondary Outcome Measures

1. Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring [Approximately 1 hour]

   Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).

2. Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring [Approximately 1 hour]

   Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.

3. Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation [Approximately 1 hour]

   Correlate respiratory volume monitoring transcutaneous carbon dioxide measurement with number of airway maneuvers to identify mechanism of hypoventilation as predominately obstructive or due to respiratory rate or tidal volume.

4. Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy [Approximately 1 hour]

   Depth of anesthesia by processed electroencephalogram (EEG) bispectral analysis, which is a standard monitor of anesthetic depth using a calibrated dimensionless index that ranges from 0 to 100, with lower numbers corresponding to a deeper anesthetic state.

5. Hypoxia Duration [Approximately 1 hour]

   The total time in seconds of oxygen saturation below 90 percent will be recorded

6. Total Number of Hypoxic Events in Subjects That Experienced Hypoxia [Approximately 1 hour]

   In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.

Other Outcome Measures

1. Short Chain Fatty Acid Concentration [Approximately 1 hour]

   Measure baseline short chain fatty acids in subjects undergoing procedural sedation for endoscopy and correlate the concentration with the degree of respiratory depression by respiratory volume monitoring and transcutaneous carbon dioxide.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.

Exclusion Criteria:

• Left ventricular Assist Device

• Severe Pulmonary Hypertension

• Ejection fraction less than 35 percent

• Active Congestive Heart Failure Exacerbation

• Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.

• Topical lidocaine administration

• Pregnancy

• Previous enrollment in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Laeben Lester, MD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 16, 2017
• Informed Consent Form - Jul 25, 2017

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03369197
• Other Study ID Numbers: IRB00118466
• First Posted: Dec 11, 2017
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• 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 Johns Hopkins University: procedural sedation; monitored anesthesia care; endoscopy
• Additional relevant MeSH terms: Hypoxia

Study Results

Participant Flow

Recruitment Details	Patients were recruited in the Endoscopy suite at Johns Hopkins Hospital.

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Period Title: Overall Study
STARTED	53	57
COMPLETED	53	57
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula	Total
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care	Total of all reporting groups
Overall Participants	53	57	110
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 56.6%	41 71.9%	71 64.5%
>=65 years	23 43.4%	16 28.1%	39 35.5%
Sex: Female, Male (Count of Participants)
Female	26 49.1%	30 52.6%	56 50.9%
Male	27 50.9%	27 47.4%	54 49.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 1.8%	1 0.9%
Not Hispanic or Latino	53 100%	56 98.2%	109 99.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 3.8%	1 1.8%	3 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 13.2%	12 21.1%	19 17.3%
White	42 79.2%	43 75.4%	85 77.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 3.8%	1 1.8%	3 2.7%

Outcome Measures

1. Primary Outcome

Title	Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
Description	Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Measure Participants	53	57
Count of Participants [Participants]	3 5.7%	16 28.1%

2. Secondary Outcome

Title	Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring
Description	Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

11 participants from intervention group and 9 participants from control group were not assessed for this outcome measure.

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Measure Participants	42	48
Mean (Standard Deviation) [mmHg]	53.3 (6.20)	51.9 (8.14)

3. Secondary Outcome

Title	Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring
Description	Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

Only 43 in the intervention group and 40 in the control group had sufficient data to be analyzed.

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Measure Participants	43	40
Mean (Standard Deviation) [percentage of decrease]	64 (21.9)	59 (22)

4. Secondary Outcome

Title	Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation
Description	Correlate respiratory volume monitoring transcutaneous carbon dioxide measurement with number of airway maneuvers to identify mechanism of hypoventilation as predominately obstructive or due to respiratory rate or tidal volume.
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Measure Participants	0	0

5. Secondary Outcome

Title	Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy
Description	Depth of anesthesia by processed electroencephalogram (EEG) bispectral analysis, which is a standard monitor of anesthetic depth using a calibrated dimensionless index that ranges from 0 to 100, with lower numbers corresponding to a deeper anesthetic state.
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

5 participants from intervention group and 7 participants from control group were not assessed for this outcome measure.

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Measure Participants	48	50
Mean (Standard Deviation) [score on a scale]	40.19 (13.64)	40.30 (15.07)

6. Secondary Outcome

Title	Hypoxia Duration
Description	The total time in seconds of oxygen saturation below 90 percent will be recorded
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Measure Participants	0	0

7. Secondary Outcome

Title	Total Number of Hypoxic Events in Subjects That Experienced Hypoxia
Description	In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

The 3 patients in nasal mask arm and 16 in nasal cannula arm experienced hypoxia.

Arm/Group Title	Intervention: Nasal Mask	Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve	Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
Measure Participants	3	16
Number [hypoxic events]	4	23

8. Other Pre-specified Outcome

Title	Short Chain Fatty Acid Concentration
Description	Measure baseline short chain fatty acids in subjects undergoing procedural sedation for endoscopy and correlate the concentration with the degree of respiratory depression by respiratory volume monitoring and transcutaneous carbon dioxide.
Time Frame	Approximately 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Discharge from endoscopy unit, up to 1 week.
Adverse Event Reporting Description	Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Arm/Group Title	Intervention: Nasal Mask		Control: Nasal Cannula
Arm/Group Description	Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve		Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care
All Cause Mortality
	Intervention: Nasal Mask		Control: Nasal Cannula
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/57 (0%)
Serious Adverse Events
	Intervention: Nasal Mask		Control: Nasal Cannula
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Intervention: Nasal Mask		Control: Nasal Cannula
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/57 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.