Trial Outcomes & Findings for The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position (NCT NCT01546636)
NCT ID: NCT01546636
Last Updated: 2019-09-30
Results Overview
Cerebral desaturation events were measured with near-infrared spectroscopy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Intraoperative-first 2 hours
Results posted on
2019-09-30
Participant Flow
A total of 70 patients presenting for elective shoulder surgery at NorthShore University HealthSystem were enrolled in the clinical trial.
All enrolled participants completed the study, and complete data was collected on all subjects.
Participant milestones
| Measure |
Hypocapnic Group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
|
Normocapnic Group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
Baseline characteristics by cohort
| Measure |
Hypocapnic Group
n=36 Participants
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
|
Normocapnic Group
n=34 Participants
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative-first 2 hoursCerebral desaturation events were measured with near-infrared spectroscopy
Outcome measures
| Measure |
Hypocapnic Group
n=36 Participants
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
|
Normocapnic Group
n=34 Participants
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
|
|---|---|---|
|
Incidence of Cerebral Desaturation Events
|
19 number of events
|
3 number of events
|
SECONDARY outcome
Timeframe: Postanesthesia care unit-first 2 hoursAssessed by recovery nurses
Outcome measures
| Measure |
Hypocapnic Group
n=36 Participants
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
|
Normocapnic Group
n=34 Participants
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
|
|---|---|---|
|
Number of Patients Experiencing Nausea and Vomiting
|
12 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Approximately 5 hoursOutcome measures
| Measure |
Hypocapnic Group
n=36 Participants
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
|
Normocapnic Group
n=34 Participants
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
|
|---|---|---|
|
Postanesthesia Care Unit Length of Stay (Total Time)
|
81.5 minutes
Interval 23.0 to 267.0
|
69 minutes
Interval 19.0 to 133.0
|
Adverse Events
Hypocapnic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normocapnic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Glenn Murphy, MD, Director of Clinical Research
NorthShore University HealthSystem
Phone: 847-570-2760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place