Trial Outcomes & Findings for High-Flow Nasal Cannula and Desaturation Episodes in the Morbidly Obese Patients (NCT NCT03148262)

NCT ID: NCT03148262

Last Updated: 2018-11-19

Results Overview

The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: Perioperative period during colonoscopy
• Results posted on: 2018-11-19

Participant Flow

A total of 63 subjects consented for the study. Four subjects disqualified.

Four subjects disqualified due to additional procedure, induction without propofol or using fentanyl.

Participant milestones

Measure	The High Flow Nasal Cannula The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation	The Standard Nasal Cannula The Salter nasal cannula will be used during the colonoscopy The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.
Overall Study STARTED	31	32
Overall Study COMPLETED	28	31
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High-Flow Nasal Cannula and Desaturation Episodes in the Morbidly Obese Patients

Baseline characteristics by cohort

Measure	The High Flow Nasal Cannula n=28 Participants The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation	The Standard Nasal Cannula n=31 Participants The Salter nasal cannula will be used during the colonoscopy The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.	Total n=59 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 7.9 • n=5 Participants	59 years STANDARD_DEVIATION 6.5 • n=7 Participants	57 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	31 participants n=7 Participants	59 participants n=5 Participants
Body Mass Index	48 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants	49 kg/m^2 STANDARD_DEVIATION 10 • n=7 Participants	49 kg/m^2 STANDARD_DEVIATION 8.5 • n=5 Participants

PRIMARY outcome

Timeframe: Perioperative period during colonoscopy

The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.

Outcome measures

Measure	The High Flow Nasal Cannula n=28 Participants The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation	The Standard Nasal Cannula n=31 Participants The Salter nasal cannula will be used during the colonoscopy The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.
The Number of Desaturation Episodes	0 Episodes Interval 0.0 to 1.0	0 Episodes Interval 0.0 to 2.0

Adverse Events

The High Flow Nasal Cannula

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

The Standard 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

Dr. Christina Riccio

UT Southwestern Medical Center

Phone: 214-590-7284

Email: Christina.Riccio@UTSouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place