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High Flow vs Standard Oxygen Delivery for Oxygen Desaturation

N/A
Waitlist Available
Led By Christina Riccio, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-80
Morbidly obese BMI equal or greater than 40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative period
Awards & highlights

Study Summary

This trial is testing whether a high flow nasal cannula or standard face mask is more effective than a standard nasal cannula in reducing desaturation events during deep intravenous sedation in obese people with a high risk of sleep apnea.

Who is the study for?
This trial is for morbidly obese adults aged 18-80 with a BMI of at least 40 and a high risk of sleep apnea (STOPBANG score ≥5), undergoing colonoscopies. It's not for those who refuse to consent, are pregnant, hemodynamically unstable, allergic to propofol, can't tolerate nasal cannula due to discomfort or need endotracheal intubation.Check my eligibility
What is being tested?
The study compares three oxygen delivery methods during colonoscopies under deep sedation in morbidly obese patients: high flow nasal cannula, standard nasal cannula, and face mask. The goal is to see which method best prevents drops in oxygen levels.See study design
What are the potential side effects?
Potential side effects may include discomfort from the different oxygen delivery devices or skin irritation. However, these interventions are generally considered safe with minimal risks when properly monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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My BMI is 40 or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative period
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oxygen saturation

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: High Floow Oxygen deliveryExperimental Treatment1 Intervention
Oxygen will be delivered by using high flow nasal cannula
Group II: Face mask groupPlacebo Group1 Intervention
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%.
Group III: Salter nasal cannulaPlacebo Group1 Intervention
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%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Flow Nasal Cannula
2016
N/A
~270

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,055 Previous Clinical Trials
1,054,726 Total Patients Enrolled
Christina Riccio, MDPrincipal InvestigatorUT Southwestern Medical Center

Media Library

Colonoscopy Sedation Clinical Trial Eligibility Overview. Trial Name: NCT03479905 — N/A
Oxygen Desaturation Research Study Groups: High Floow Oxygen delivery, Face mask group, Salter nasal cannula
Oxygen Desaturation Clinical Trial 2023: Colonoscopy Sedation Highlights & Side Effects. Trial Name: NCT03479905 — N/A
Colonoscopy Sedation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03479905 — N/A
~20 spots leftby Jun 2025
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