Trial Outcomes & Findings for The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients (NCT NCT03479905)
NCT ID: NCT03479905
Last Updated: 2024-08-13
Results Overview
The frequency of desaturation episodes (SpO2 \<90%)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
Intraoperative period, an average of 1 hour
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Salter Nasal Cannula
A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%
Salter nasal cannula: Oxygen will be delivered by using standard nasal cannula
|
Face Mask Group
A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.
Face mask: Oxygen will be delivered via face mask during colonoscopy
|
High Flow Oxygen Delivery
Oxygen will be delivered by using high flow nasal cannula
High Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
48
|
|
Overall Study
COMPLETED
|
43
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
5
|
Reasons for withdrawal
| Measure |
Salter Nasal Cannula
A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%
Salter nasal cannula: Oxygen will be delivered by using standard nasal cannula
|
Face Mask Group
A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.
Face mask: Oxygen will be delivered via face mask during colonoscopy
|
High Flow Oxygen Delivery
Oxygen will be delivered by using high flow nasal cannula
High Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.
|
|---|---|---|---|
|
Overall Study
Other airway method used
|
4
|
5
|
5
|
Baseline Characteristics
The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients
Baseline characteristics by cohort
| Measure |
Salter Nasal Cannula
n=43 Participants
A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%
Salter nasal cannula: Oxygen will be delivered by using standard nasal cannula
|
Face Mask Group
n=43 Participants
A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.
Face mask: Oxygen will be delivered via face mask during colonoscopy
|
High Flow Oxygen Delivery
n=43 Participants
Oxygen will be delivered by using high flow nasal cannula
High Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.55 years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
58.23 years
STANDARD_DEVIATION 6.73 • n=7 Participants
|
57.55 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
57.44 years
STANDARD_DEVIATION 8.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
43 participants
n=5 Participants
|
129 participants
n=4 Participants
|
|
Stop Bang Score
|
6 Stop Bang Score on a scale of 0 to 8
n=5 Participants
|
6 Stop Bang Score on a scale of 0 to 8
n=7 Participants
|
6 Stop Bang Score on a scale of 0 to 8
n=5 Participants
|
6 Stop Bang Score on a scale of 0 to 8
n=4 Participants
|
|
Preoperative oxygen saturation (SpO2)
|
97.5 Percentage of oxygen saturation
n=5 Participants
|
98 Percentage of oxygen saturation
n=7 Participants
|
97 Percentage of oxygen saturation
n=5 Participants
|
98 Percentage of oxygen saturation
n=4 Participants
|
PRIMARY outcome
Timeframe: Intraoperative period, an average of 1 hourThe frequency of desaturation episodes (SpO2 \<90%)
Outcome measures
| Measure |
Salter Nasal Cannula
n=43 Participants
A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%
Salter nasal cannula: Oxygen will be delivered by using standard nasal cannula
|
Face Mask Group
n=43 Participants
A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.
Face mask: Oxygen will be delivered via face mask during colonoscopy
|
High Flow Oxygen Delivery
n=43 Participants
Oxygen will be delivered by using high flow nasal cannula
High Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.
|
|---|---|---|---|
|
Oxygen Saturation (SpO2 )
|
0 Desaturation episodes
Interval 0.0 to 2.0
|
0 Desaturation episodes
Interval 0.0 to 1.0
|
0 Desaturation episodes
Interval 0.0 to 0.0
|
Adverse Events
Salter Nasal Cannula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Face Mask Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Flow Oxygen Delivery
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