Trial Outcomes & Findings for EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation (NCT NCT02590406)
NCT ID: NCT02590406
Last Updated: 2020-03-25
Results Overview
Change of Non-hypoxic apnea time in obese patient during a General Anesthesia induction, as a result of different pre-oxygenation position and ventilation mode; 1-Beach Chair and No positive pressure ventilation, 2-Reverse Trendelenburg and positive pressure ventilation and PEEP. End of measure time frame is 5 minutes after intubation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
After a 3 minutes pre-oxygenation period
Results posted on
2020-03-25
Participant Flow
Recruitment between September and December 2015 on the bariatric surgery ward during the preoperative assessment.
Files were evaluated in order to see if the patients met the inclusion criteria, if they had any exclusion criteria. Then the trial was explained to them and they could choose wether they wanted to participate or not. 75 patients files were evaluated, 53 were solicitated, 3 refused to participate.
Participant milestones
| Measure |
Beach Chair (BC) and ZEEP
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Beach Chair (BC) and ZEEP
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Saturometer malfunction
|
0
|
1
|
Baseline Characteristics
We evaluated the FEV1 of the patients we had in the files
Baseline characteristics by cohort
| Measure |
Beach Chair (BC) and ZEEP
n=24 Participants
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
n=24 Participants
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 11.1 • n=24 Participants
|
40.8 years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
43.5 years
STANDARD_DEVIATION 10.2 • n=48 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
34 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
14 Participants
n=48 Participants
|
|
Region of Enrollment
Canada
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
48 Participants
n=48 Participants
|
|
Weight (kg)
|
129 kilogram
STANDARD_DEVIATION 20.8 • n=24 Participants
|
131.7 kilogram
STANDARD_DEVIATION 11.1 • n=24 Participants
|
130.4 kilogram
STANDARD_DEVIATION 10.2 • n=48 Participants
|
|
Height (m)
|
1.6 centimeters
STANDARD_DEVIATION 0.1 • n=24 Participants
|
1.7 centimeters
STANDARD_DEVIATION 0.1 • n=24 Participants
|
1.7 centimeters
STANDARD_DEVIATION 0.1 • n=48 Participants
|
|
BMI (m/kg2)
|
47.3 kilogram per meter square
STANDARD_DEVIATION 5.2 • n=24 Participants
|
47.9 kilogram per meter square
STANDARD_DEVIATION 6.3 • n=24 Participants
|
47.6 kilogram per meter square
STANDARD_DEVIATION 5.7 • n=48 Participants
|
|
Waist circumference (cm)
|
113.5 centimeters
STANDARD_DEVIATION 14.7 • n=24 Participants
|
138.4 centimeters
STANDARD_DEVIATION 15 • n=24 Participants
|
136.1 centimeters
STANDARD_DEVIATION 14.7 • n=48 Participants
|
|
Hip circumference (cm)
|
136.4 centimeters
STANDARD_DEVIATION 11.1 • n=24 Participants
|
142.8 centimeters
STANDARD_DEVIATION 14.8 • n=24 Participants
|
139.6 centimeters
STANDARD_DEVIATION 13.3 • n=48 Participants
|
|
Waist:hip ratio
|
1.0 ratio
STANDARD_DEVIATION 0.1 • n=24 Participants
|
1.0 ratio
STANDARD_DEVIATION 0.1 • n=24 Participants
|
1.0 ratio
STANDARD_DEVIATION 0.1 • n=48 Participants
|
|
Neck Circumference
|
44.9 centimeters
STANDARD_DEVIATION 4.8 • n=24 Participants
|
43.9 centimeters
STANDARD_DEVIATION 5.9 • n=24 Participants
|
44.4 centimeters
STANDARD_DEVIATION 5.3 • n=48 Participants
|
|
FEV1 (liters)
|
2.8 liters
STANDARD_DEVIATION 0.6 • n=15 Participants • We evaluated the FEV1 of the patients we had in the files
|
2.9 liters
STANDARD_DEVIATION 0.8 • n=19 Participants • We evaluated the FEV1 of the patients we had in the files
|
2.9 liters
STANDARD_DEVIATION 0.7 • n=34 Participants • We evaluated the FEV1 of the patients we had in the files
|
|
Sleep apnea Dx (n)
|
11 participants
n=24 Participants
|
12 participants
n=24 Participants
|
23 participants
n=48 Participants
|
|
CPAP
|
9 participants
n=24 Participants
|
10 participants
n=24 Participants
|
19 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: After a 3 minutes pre-oxygenation periodChange of Non-hypoxic apnea time in obese patient during a General Anesthesia induction, as a result of different pre-oxygenation position and ventilation mode; 1-Beach Chair and No positive pressure ventilation, 2-Reverse Trendelenburg and positive pressure ventilation and PEEP. End of measure time frame is 5 minutes after intubation
Outcome measures
| Measure |
Beach Chair (BC) and ZEEP
n=24 Participants
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
n=24 Participants
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
|---|---|---|
|
Non Hypoxic Apnea Time
|
216.7 seconds
Standard Deviation 42.3
|
258.2 seconds
Standard Deviation 55.1
|
SECONDARY outcome
Timeframe: During the pre-oxygenation periodEvaluation of time needed to obtain an expired fraction of oxygen of \> 0,9 in the two groups during the pre-oxygenation
Outcome measures
| Measure |
Beach Chair (BC) and ZEEP
n=24 Participants
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
n=24 Participants
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
|---|---|---|
|
Time to Expired Oxygen Fraction > 0,9
|
145.3 seconds
Standard Deviation 40.8
|
85.1 seconds
Standard Deviation 47.8
|
SECONDARY outcome
Timeframe: After 3 minutes of pre-oxygenationEvaluation of the maximum expired oxygen fraction obtained in the two groups
Outcome measures
| Measure |
Beach Chair (BC) and ZEEP
n=24 Participants
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
n=24 Participants
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
|---|---|---|
|
Maximum Expired Fraction of Oxygen Obtained
|
0.89 Maximum expired fraction of oxygen obtai
Standard Deviation 0.01
|
0.91 Maximum expired fraction of oxygen obtai
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: After the end of the Non-hypoxic apnea timePopulation: One patient missing in the BC group
Evaluation of the minimal saturation obtained after the resumption of the ventilation
Outcome measures
| Measure |
Beach Chair (BC) and ZEEP
n=23 Participants
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
n=24 Participants
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
|---|---|---|
|
Minimum Arterial Saturation of Oxygen Obtained
|
83.6 percent
Standard Deviation 0.9
|
85.3 percent
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Evaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97%Population: 4 values missing in the BC group and 5 values missing in RT group.
Outcome measures
| Measure |
Beach Chair (BC) and ZEEP
n=21 Participants
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
|
Reverse Trendelenburg and NIPPV
n=20 Participants
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
|
|---|---|---|
|
Time to 97% Saturation
|
88.4 seconds
Standard Deviation 17.3
|
68 seconds
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: From the beginning of the pre-oxygenation to the end of the protocolEvaluation of the changes in vital signs during and after the pre-oxygenation phase in the two combinations of position and ventilation mode
Outcome measures
Outcome data not reported
Adverse Events
Beach Chair (BC) and ZEEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reverse Trendelenburg and NIPPV
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
Dr Jean S Bussières
Institut universitaire Cardiologie et Pneumologie de Québec
Phone: 418-656-8711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place