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Procedure
SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) for Sleep Apnea
N/A
Waitlist Available
Led By Erikka Washington, MD
Research Sponsored by The University of Texas Health Science Center, Houston
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 end of procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial compares a special nasal device that helps keep airways open to regular oxygen masks in obese patients or those with sleep apnea during colonoscopy. The goal is to see which method better supports breathing.
Eligible Conditions
- Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to endoscopic intubation,during the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to endoscopic intubation,during the procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Anesthesiologist satisfaction score as assessed by the visual analog scale (VAS)
Change in alertness of subject as assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)
Patient satisfaction as assessed by the visual analog scale (VAS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group B: SuperNO2VA™EtCO2Experimental Treatment1 Intervention
Group II: Group A: Standard care with a facemask.Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
2022
N/A
~140
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,150 Total Patients Enrolled
Vyaire MedicalIndustry Sponsor
9 Previous Clinical Trials
885 Total Patients Enrolled
Erikka Washington, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you need to have an unplanned surgery or medical procedure during the study.You have had an allergic reaction to propofol in the past.You are currently experiencing a worsening of congestive heart failure.You have a sudden worsening of respiratory conditions like COPD or asthma.You have a surgically-created opening in your windpipe called a tracheostomy.You are currently having a medical procedure called a colonoscopy.You are ASA physical status I, II, or III.You have a tumor located in the upper part of your voice box or just below it.You are not eligible to use the SuperNoVa software.You have a high body mass index (BMI) of 35 or above, or have been diagnosed with or suspected to have obstructive sleep apnea.You have untreated heart disease caused by reduced blood flow.You are pregnant.You have a blockage or slow movement in your digestive system.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Standard care with a facemask.
- Group 2: Group B: SuperNO2VA™EtCO2
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.
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