The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

• Sponsor: NorthShore University HealthSystem (Other)
• Overall Status: Completed
• CT.gov ID: NCT01546636
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)

Condition or Disease	Intervention/Treatment	Phase
Cerebral Ischemia	Other: Hypocapnic group; Other: Normocapnic group	N/A

Detailed Description

Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Hypocapnic group Patients will be ventilated to an ETCO2 of 30-32 mm Hg.	Other: Hypocapnic group; Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Active Comparator: Normocapnic group Patients will be ventilated to an ETCO2 of 40-42 mm Hg	Other: Normocapnic group; Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Outcome Measures

Primary Outcome Measures

1. Incidence of Cerebral Desaturation Events [Intraoperative-first 2 hours]

   Cerebral desaturation events were measured with near-infrared spectroscopy

Secondary Outcome Measures

1. Number of Patients Experiencing Nausea and Vomiting [Postanesthesia care unit-first 2 hours]

   Assessed by recovery nurses

2. Postanesthesia Care Unit Length of Stay (Total Time) [Approximately 5 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.

Exclusion Criteria:

• Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University HealthSystem	Evanston	Illinois	United States	60201

Sponsors and Collaborators

• NorthShore University HealthSystem

Investigators

• Principal Investigator: Glenn S. Murphy, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glenn Murphy, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem
• ClinicalTrials.gov Identifier: NCT01546636
• Other Study ID Numbers: EH10-184
• First Posted: Mar 7, 2012
• Last Update Posted: Sep 30, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Glenn Murphy, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem: Cerebral desaturation events; Cerebral oximetry; Beach chair position
• Additional relevant MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia

Study Results

Participant Flow

Recruitment Details	A total of 70 patients presenting for elective shoulder surgery at NorthShore University HealthSystem were enrolled in the clinical trial.
Pre-assignment Detail	All enrolled participants completed the study, and complete data was collected on all subjects.

Arm/Group Title	Hypocapnic Group	Normocapnic Group
Arm/Group Description	Patients will be ventilated to an ETCO2 of 30-32 mm Hg.	Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Period Title: Overall Study
STARTED	36	34
COMPLETED	36	34
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Hypocapnic Group	Normocapnic Group	Total
Arm/Group Description	Patients will be ventilated to an ETCO2 of 30-32 mm Hg.	Patients will be ventilated to an ETCO2 of 40-42 mm Hg	Total of all reporting groups
Overall Participants	36	34	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	31 86.1%	30 88.2%	61 87.1%
>=65 years	5 13.9%	4 11.8%	9 12.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.3 (13.8)	54.7 (12.4)	53.3 (12.8)
Sex: Female, Male (Count of Participants)
Female	26 72.2%	24 70.6%	50 71.4%
Male	10 27.8%	10 29.4%	20 28.6%
Region of Enrollment (participants) [Number]
United States	36 100%	34 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Cerebral Desaturation Events
Description	Cerebral desaturation events were measured with near-infrared spectroscopy
Time Frame	Intraoperative-first 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hypocapnic Group	Normocapnic Group
Arm/Group Description	Patients will be ventilated to an ETCO2 of 30-32 mm Hg.	Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Measure Participants	36	34
Number [number of events]	19	3

2. Secondary Outcome

Title	Number of Patients Experiencing Nausea and Vomiting
Description	Assessed by recovery nurses
Time Frame	Postanesthesia care unit-first 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hypocapnic Group	Normocapnic Group
Arm/Group Description	Patients will be ventilated to an ETCO2 of 30-32 mm Hg.	Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Measure Participants	36	34
Number [participants]	12 33.3%	3 8.8%

3. Secondary Outcome

Title	Postanesthesia Care Unit Length of Stay (Total Time)
Time Frame	Approximately 5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hypocapnic Group	Normocapnic Group
Arm/Group Description	Patients will be ventilated to an ETCO2 of 30-32 mm Hg.	Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Measure Participants	36	34
Median (Full Range) [minutes]	81.5	69

Adverse Events

Time Frame	Until the time of hospital discharge
Adverse Event Reporting Description	Patients were followed until hospital discharge
Arm/Group Title	Hypocapnic Group		Normocapnic Group
Arm/Group Description	Patients will be ventilated to an ETCO2 of 30-32 mm Hg.		Patients will be ventilated to an ETCO2 of 40-42 mm Hg
All Cause Mortality
	Hypocapnic Group		Normocapnic Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Hypocapnic Group		Normocapnic Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Hypocapnic Group		Normocapnic Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/34 (0%)

Limitations/Caveats

There were no technical limitations to the trial

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.