Trial Outcomes & Findings for Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position (NCT NCT01535274)
NCT ID: NCT01535274
Last Updated: 2022-04-06
Results Overview
rSO2 will be recorded as a "snap shot." A mean value from right and left sides will be calculated for each patient at each study point. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. With each set point, the value shown is the absolute change from baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
duration of surgery, generally no more than 90 minutes total
Results posted on
2022-04-06
Participant Flow
Ten potential participants were excluded for not meeting inclusion criteria, declination to participate, and other reasons.
Participant milestones
| Measure |
Propofol
Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
Desflurane
Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
Received Propofol
|
28
|
1
|
|
Overall Study
Received Desflurane
|
0
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Propofol
Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
Desflurane
Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
|---|---|---|
|
Overall Study
Determined to be ineligible
|
0
|
1
|
|
Overall Study
Misallocated to propofol intervention
|
0
|
1
|
Baseline Characteristics
Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position
Baseline characteristics by cohort
| Measure |
Propofol
n=29 Participants
Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
Desflurane
n=27 Participants
Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
50.34 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: duration of surgery, generally no more than 90 minutes totalPopulation: Of the 29 participants initially randomized to receive desflurane treatment, one participant initially randomized to the desflurane arm was misallocated to the propofol arm and received propofol treatment, so is included in the propofol arm here.
rSO2 will be recorded as a "snap shot." A mean value from right and left sides will be calculated for each patient at each study point. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. With each set point, the value shown is the absolute change from baseline.
Outcome measures
| Measure |
Propofol
n=29 Participants
Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
Desflurane
n=27 Participants
Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
|---|---|---|
|
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
Set Point 1: FIO2 30%; PETCO2 30mmHg (Supine)
|
-4.27 Percent oxygen saturation
Standard Deviation 8.43
|
-0.70 Percent oxygen saturation
Standard Deviation 10.08
|
|
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
Set Point 2: FIO2 30%; PETCO2 30mmHg (Beach Chair)
|
-15.48 Percent oxygen saturation
Standard Deviation 11.35
|
-10.90 Percent oxygen saturation
Standard Deviation 7.03
|
|
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
Set Point 3: FIO2 100%; PETCO2 30mmHg (Beach Chair)
|
-8.31 Percent oxygen saturation
Standard Deviation 11.21
|
-3.14 Percent oxygen saturation
Standard Deviation 7.21
|
|
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
Set Point 4: FIO2 100%; PETCO2 45mmHg (Beach Chair)
|
5.46 Percent oxygen saturation
Standard Deviation 9.79
|
9.20 Percent oxygen saturation
Standard Deviation 7.01
|
|
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
Set Point 5: FIO2 30%; PETCO2 30mmHg (Beach Chair)
|
-9.00 Percent oxygen saturation
Standard Deviation 11.02
|
-3.59 Percent oxygen saturation
Standard Deviation 7.67
|
PRIMARY outcome
Timeframe: duration of surgery, generally no more than 90 minutes totalPopulation: Of the 29 participants initially randomized to receive desflurane treatment, one participant initially randomized to the desflurane arm was misallocated to the propofol arm and received propofol treatment, so is included in the propofol arm here.
Regional cerebral oxygenation (rSO2) values at the set ventilatory points of the study for each anesthetic choice. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
Outcome measures
| Measure |
Propofol
n=29 Participants
Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
Desflurane
n=27 Participants
Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.
Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
3. FIO2 100%, PETCO2 30mmHg - beach chair position.
4. FIO2 100%, PETCO2 45mmHg - beach chair position.
5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
|
|---|---|---|
|
Regional Cerebral Oxygenation (rSO2) Values
Set Point 5: Fio2 0.3 Petco2 30 mmHg
|
64 Percentage cerebral oxygen saturation
Standard Deviation 14
|
67 Percentage cerebral oxygen saturation
Standard Deviation 12
|
|
Regional Cerebral Oxygenation (rSO2) Values
Set Point 1: Fio2 0.3 Petco2 30 mmHg
|
67 Percentage cerebral oxygen saturation
Standard Deviation 13
|
69 Percentage cerebral oxygen saturation
Standard Deviation 11
|
|
Regional Cerebral Oxygenation (rSO2) Values
Set Point 2: Fio2 0.3 Petco2 30 mmHg
|
59 Percentage cerebral oxygen saturation
Standard Deviation 13
|
62 Percentage cerebral oxygen saturation
Standard Deviation 10
|
|
Regional Cerebral Oxygenation (rSO2) Values
Set Point 3: Fio2 1.0 Petco2 30 mmHg
|
64 Percentage cerebral oxygen saturation
Standard Deviation 14
|
67 Percentage cerebral oxygen saturation
Standard Deviation 11
|
|
Regional Cerebral Oxygenation (rSO2) Values
Set Point 4: Fio2 1.0 Petco2 45 mmHg
|
74 Percentage cerebral oxygen saturation
Standard Deviation 12
|
76 Percentage cerebral oxygen saturation
Standard Deviation 11
|
Adverse Events
Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Desflurane
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place