CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
The Comfort Flo system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03148262
NCT03148262N/ACompleted

Use of High-Flow Nasal Cannula to Prevent Desaturation Episodes in the Morbidly Obese Patients Undergoing Colonoscopy:A Prospective Randomized Clinical Trial

University of Texas Southwestern Medical Center·interventional·Posted May 10, 2017·Updated Nov 19, 2018

In Brief

A clinical study evaluating The Comfort Flo system and The Salter nasal cannula for Desaturation of Blood and 4 related conditions. Completed, enrolled 59 participants across 2 sites.

Detailed Summary

It is standard practice in the United States and many parts of world to perform Gastrointestinal (GI) endoscopy with the patient under deep sedation. Obesity is accepted as a patient specific risk factor for hypoxic events during procedural sedation for GI endoscopic procedures. The Obese population has a higher prevalence of obstructive sleep apnea (OSA) which is characterized by repeated obstruction of the upper airway, and leads to apnea and desaturation. This prospective, randomized study was designed to compare the effectiveness of the high flow nasal cannula and the standard nasal cannula in morbidly obese (BMI \> 40) patients receiving deep intravenous sedation during colonoscopies. This study will assess whether use of the high flow nasal cannula (HFNC) leads to less intraoperative desaturation events compared to the current standard of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 10, 2017
Enrollment StartMay 10, 2017
Primary CompletionAug 28, 2017
Study CompletionJan 22, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.1 years ago

Interventions

The Comfort Flo systemdevice

The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation

The Salter nasal cannuladevice

A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.