Trial Outcomes & Findings for The Performance of Two Oxygen Delivery Devices Used After General Anesthesia. (NCT NCT01917526)
NCT ID: NCT01917526
Last Updated: 2017-01-04
Results Overview
Hypoxemia is defined as oxygen saturation \< 94%. We record number of participants with hypoxemia in both groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
In PACU (1 hr after anesthesia)
Results posted on
2017-01-04
Participant Flow
Participant milestones
| Measure |
Oxygen Mask
Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask
|
Oxygen Cannula
Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
|
Overall Study
COMPLETED
|
249
|
249
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Oxygen Mask
Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask
|
Oxygen Cannula
Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.
Baseline characteristics by cohort
| Measure |
Oxygen Mask
n=250 Participants
Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask
|
Oxygen Cannula
n=250 Participants
Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
48.65 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Gender
Female
|
180 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Gender
Male
|
70 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
250 participants
n=5 Participants
|
250 participants
n=7 Participants
|
500 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: In PACU (1 hr after anesthesia)Hypoxemia is defined as oxygen saturation \< 94%. We record number of participants with hypoxemia in both groups
Outcome measures
| Measure |
Oxygen Mask
n=250 Participants
Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask
|
Oxygen Cannula
n=250 Participants
Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula
|
|---|---|---|
|
Number of Participants With Hypoxemia in Both Groups
|
0 number of participants
|
0 number of participants
|
SECONDARY outcome
Timeframe: In PACU (1 hr after anesthesia)Causes of hypoxemia in each participant in PACU will be recorded
Outcome measures
| Measure |
Oxygen Mask
n=250 Participants
Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask
|
Oxygen Cannula
n=250 Participants
Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula
|
|---|---|---|
|
The Causes of Hypoxemia
|
0 causes of hypoxemia
|
0 causes of hypoxemia
|
Adverse Events
Oxygen Mask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxygen Cannula
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
Department of Anesthesiology, Siriraj Hospital
Mahidol University
Phone: 66-2-41979889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place