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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative period

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,583 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants able to enroll in this research endeavor?

"According to information on clinicaltrials.gov, this research endeavour is not currently enrolling participants; the trial was initially posted in March 2018 and last updated on May 31st 2022. Despite being closed for recruitment at present time, 18 other trials are actively accepting new patients."

Answered by AI

Would I be eligible to participate in this experiment?

"This research project is looking to enrol 216 individuals who have recently undergone colonoscopy and are between 18-80 years old. Additionally, these candidates must have a BMI of at least 40 or higher as well as a STOPBANG score equal to or greater than 5."

Answered by AI

Are applicants of 40 years or older being considered for inclusion in this investigation?

"The requirements for this medical trial necessitate that applicants are between 18 and 80 years old. Additionally, there is a separate study planned for individuals under the age of eighteen while sixteen studies have been designated to those over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients

Christina Riccio 2018. "The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03479905.