Trial Outcomes & Findings for Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite (NCT NCT02859597)
NCT ID: NCT02859597
Last Updated: 2020-04-16
Results Overview
The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
During the period of sedation, on average up to 1 hour
Results posted on
2020-04-16
Participant Flow
Participant milestones
| Measure |
High Flow Nasal Cannula
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
Nasal Cannula
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
19
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Flow Nasal Cannula
n=22 Participants
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
Nasal Cannula
n=19 Participants
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
19 Participants
n=19 Participants
|
41 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 12.5 • n=22 Participants
|
43.4 years
STANDARD_DEVIATION 12.2 • n=19 Participants
|
46 years
STANDARD_DEVIATION 12.3 • n=41 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=22 Participants
|
15 Participants
n=19 Participants
|
34 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=22 Participants
|
4 Participants
n=19 Participants
|
7 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: During the period of sedation, on average up to 1 hourThe ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.
Outcome measures
| Measure |
High Flow Nasal Canula
n=22 Participants
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
Nasal Canula
n=19 Participants
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
|---|---|---|
|
Ability to Maintain Oxygenation
|
0.55 manipulations
Standard Deviation 0.55
|
0.61 manipulations
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: During the period of sedation, on average up to 1 hourThe use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.
Outcome measures
| Measure |
High Flow Nasal Canula
n=22 Participants
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
Nasal Canula
n=19 Participants
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
|---|---|---|
|
Number of Participants Requiring Airway Adjuncts During Procedure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During period of sedation, on average up to 1 hourNeed to increase the FiO2 to maintain adequate oxygenation
Outcome measures
| Measure |
High Flow Nasal Canula
n=22 Participants
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
Nasal Canula
n=19 Participants
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
|
|---|---|---|
|
Number of Participants Who Need an Increase in Fraction of Inspired Oxygen
|
6 Participants
|
3 Participants
|
Adverse Events
High Flow Nasal Cannula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nasal 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place