Trial Outcomes & Findings for Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation? (NCT NCT00715741)
NCT ID: NCT00715741
Last Updated: 2010-02-18
Results Overview
Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 \>90%.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
100 participants
Primary outcome timeframe
45 min after emergence (tracheal extubation)
Results posted on
2010-02-18
Participant Flow
Recruitment started 06/24/2008 and ended 07/07/2009. Subjects were recruited via the Operating room schedule
Participant milestones
| Measure |
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP
30% oxygen with positive end expiratory pressure (PEEP)
|
Fi02 0.3 Without PEEP
30% oxygen without PEEP
|
Fi02 0.9 With PEEP
90% oxygen plus PEEP
|
Fi02 0.9 Without PEEP
90% oxygen without PEEP
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
Baseline characteristics by cohort
| Measure |
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP
n=25 Participants
30% oxygen with positive end expiratory pressure (PEEP)
|
Fi02 0.3 Without PEEP
n=25 Participants
30% oxygen without PEEP
|
Fi02 0.9 With PEEP
n=25 Participants
90% oxygen plus PEEP
|
Fi02 0.9 Without PEEP
n=25 Participants
90% oxygen without PEEP
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Age, Customized
Between 18 and 65 years
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
24 participants
n=5 Participants
|
23 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Age Continuous
|
47 years
STANDARD_DEVIATION 13 • n=5 Participants
|
45 years
STANDARD_DEVIATION 12 • n=7 Participants
|
46 years
STANDARD_DEVIATION 15 • n=5 Participants
|
46 years
STANDARD_DEVIATION 13 • n=4 Participants
|
46 years
STANDARD_DEVIATION 13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
100 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 45 min after emergence (tracheal extubation)Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 \>90%.
Outcome measures
| Measure |
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP
n=25 Participants
30% oxygen with positive end expiratory pressure (PEEP)
|
Fi02 0.3 Without PEEP
n=25 Participants
30% oxygen without PEEP
|
Fi02 0.9 With PEEP
n=25 Participants
90% oxygen plus PEEP
|
Fi02 0.9 Without PEEP
n=25 Participants
90% oxygen without PEEP
|
|---|---|---|---|---|
|
Oxygen Requirement to Maintain SpO2>90%
|
1 liters per minute
Interval 0.5 to 2.0
|
1 liters per minute
Interval 0.5 to 2.0
|
1 liters per minute
Interval 0.5 to 2.0
|
1 liters per minute
Interval 0.5 to 2.0
|
PRIMARY outcome
Timeframe: 24 hours after tracheal extubationamount of oxygen (LPM) required to maintain SpO2 \>90%
Outcome measures
| Measure |
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP
n=25 Participants
30% oxygen with positive end expiratory pressure (PEEP)
|
Fi02 0.3 Without PEEP
n=25 Participants
30% oxygen without PEEP
|
Fi02 0.9 With PEEP
n=25 Participants
90% oxygen plus PEEP
|
Fi02 0.9 Without PEEP
n=25 Participants
90% oxygen without PEEP
|
|---|---|---|---|---|
|
Oxygen Requirement
|
0.5 liters per min
Interval 0.5 to 2.0
|
0.5 liters per min
Interval 0.5 to 2.0
|
1.0 liters per min
Interval 0.5 to 2.0
|
0.5 liters per min
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: 45 min after tracheal extubationSpO2 measured on room air or minimum supplemental oxygen to keep SpO2\>90%
Outcome measures
| Measure |
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP
n=25 Participants
30% oxygen with positive end expiratory pressure (PEEP)
|
Fi02 0.3 Without PEEP
n=25 Participants
30% oxygen without PEEP
|
Fi02 0.9 With PEEP
n=25 Participants
90% oxygen plus PEEP
|
Fi02 0.9 Without PEEP
n=25 Participants
90% oxygen without PEEP
|
|---|---|---|---|---|
|
Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"
|
95 percent saturation
Standard Deviation 2
|
96 percent saturation
Standard Deviation 2
|
95 percent saturation
Standard Deviation 2
|
95 percent saturation
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 24 hours after tracheal extubationSpO2 is measured on room air or minimum oxygen required to keep SpO2\>90% on the ward 24 hours after tracheal extubation.
Outcome measures
| Measure |
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP
n=25 Participants
30% oxygen with positive end expiratory pressure (PEEP)
|
Fi02 0.3 Without PEEP
n=25 Participants
30% oxygen without PEEP
|
Fi02 0.9 With PEEP
n=25 Participants
90% oxygen plus PEEP
|
Fi02 0.9 Without PEEP
n=25 Participants
90% oxygen without PEEP
|
|---|---|---|---|---|
|
SpO2 Postoperatively
|
95 percent saturation
Standard Deviation 2
|
95 percent saturation
Standard Deviation 2
|
95 percent saturation
Standard Deviation 2
|
95 percent saturation
Standard Deviation 2
|
Adverse Events
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fi02 0.3 Without PEEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fi02 0.9 With PEEP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fi02 0.9 Without PEEP
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