Your session is about to expire
← Back to Search
High-flow Oxygen +/− Nasal PAP for Colonoscopy Patients
N/A
Waitlist Available
Led By John DeWitt, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes
Awards & highlights
Study Summary
This trial will compare levels of oxygen desaturation in high risk patients receiving propofol sedation during colonoscopy, randomized to nasal mask or nasal cannula.
Who is the study for?
This trial is for high-risk adults (18+) with a BMI of 35 or higher, or those with documented sleep apnea. They must be undergoing an upper colonoscopy and have no acute respiratory issues, previous severe reactions to propofol, obstructive lesions in the colon, heart failure exacerbation, untreated heart disease, or be pregnant.Check my eligibility
What is being tested?
The study compares two methods of oxygen delivery during sedated colonoscopies: standard nasal cannula versus a nasal mask with positive airway pressure (PAP). Patients are randomly assigned to one of these groups to assess oxygen levels and satisfaction post-procedure.See study design
What are the potential side effects?
Potential side effects may include discomfort from the nasal devices used for oxygen delivery and possible complications related to propofol sedation such as low blood pressure, slow breathing rate, or allergic reaction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of oxygen desaturation
Incidence of desaturation
Severity of oxygen desaturation
Secondary outcome measures
Duration of Airway maneuvers
Duration of Procedural Interruption
Endoscope Insertion
+18 moreTrial Design
2Treatment groups
Active Control
Group I: Group B: SuperNO2VA™EtCO2Active Control1 Intervention
Group B will be given a nasal oxygen to deliver gas, create a seal, and provide positive pressure. The mask will be placed over a patient's nose and connected to either an anesthesia circuit or hyperinflation bag during respiratory, anesthesia, and resuscitation procedures.
Group II: Group A: standard care with a nasal cannula.Active Control1 Intervention
Group A will be given the standard nasal cannula during sedation. The cannula prongs will be inserted into the patient's nose to provide oxygen to the patient.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,982 Total Patients Enrolled
John DeWitt, MDPrincipal InvestigatorProfessor of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently experiencing a severe worsening of your respiratory condition such as COPD or asthma.You have a surgical opening in your windpipe called a tracheostomy.You have had surgery on your colon before.If you need to have an unexpected medical procedure during the trial.You have severe obesity (a body mass index of 35 or higher) or a medical condition called obstructive sleep apnea.You are experiencing a worsening of congestive heart failure symptoms.You have a tumor located above or below your vocal cords.You have a blockage or slow-moving digestive system, which can include conditions like an enlarged colon or difficulty swallowing.You are pregnant.You are having a medical procedure called an upper colonoscopy.You have heart disease that has not been treated.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: SuperNO2VA™EtCO2
- Group 2: Group A: standard care with a nasal cannula.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers still being sought for this research endeavor?
"The details on clinicaltrials.gov suggest that this medical research is no longer recruiting test-subjects. It was initially posted in April 1st 2023 and last amended in March 2nd 2023, but there are 22 other trials actively searching for patients presently."
Answered by AI
What key goals is this medical trial striving to achieve?
"In order to measure the main outcome of this trial, which span a window of 60 minutes, researchers are tracking oxygen desaturation levels. Secondary objectives include monitoring Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) scores before and during endoscope insertion; measuring how long it takes for patients to reach an acceptable level of sedation after induction (i.e., MOAAS <4); and tallying up the number airway maneuvers taken by medical professionals throughout the procedure."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger