Group B: SuperNO2VA™EtCO2 for Obstructive Sleep Apnea, Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Obstructive Sleep Apnea, Obesity+3 More
SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).

Eligible Conditions

  • Obstructive Sleep Apnea, Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: at time of discharge(about one hour form end of procedure)

Within 5 minutes of the start of anesthesia
Amount of propofol administered during induction
at time of discharge( about one hour form end of procedure)
Recovery time as assessed by the actual time when subject was discharged
Recovery time as assessed by the time when subject was ready for discharge
at time of discharge(about one hour form end of procedure)
Patient satisfaction as assessed by the visual analog scale (VAS)
end of endoscopy procedure( about 45 minutes form start of procedure)
Time taken from initiation of induction to the first airway intervention
end of procedure
Anesthesiologist satisfaction score as assessed by the visual analog scale (VAS)
end of procedure (about 45 minutes after start)
Total amount of propofol administered during the procedure
end of procedure (about 45 minutes form start)
Duration of procedural interruptions as assessed by the length of time the endoscope is removed from the patient
Incidence of procedural interruptions as assessed by the number of times the endoscope is removed from the patient
Number of participants who received airway maneuvers
Reason for airway maneuvers
Time taken for airway maneuvers
Time taken for the entire procedure
from start of procedure to end of procedure (about 45 minutes)
Number of participants that had incidences of cardiac complications
Number of participants that tolerated the SuperNO2VA™EtCO2
prior to endoscopic intubation,during the procedure
Change in alertness of subject as assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)
within 5 minutes of start of sedation
Time taken from induction to endoscopic insertion

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Group A: Standard care with a facemask.
1 of 2
Group B: SuperNO2VA™EtCO2
1 of 2
Active Control
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Group B: SuperNO2VA™EtCO2 · No Placebo Group · N/A

Group B: SuperNO2VA™EtCO2
Device
Experimental Group · 1 Intervention: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) · Intervention Types: Device
Group A: Standard care with a facemask.
Device
ActiveComparator Group · 1 Intervention: Standard care with a facemask. · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at time of discharge(about one hour form end of procedure)

Trial Background

Prof. Erikka L Washington, Assistant Professor
Principal Investigator
The University of Texas Health Science Center, Houston
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
2008First Recorded Clinical Trial
1 TrialsResearching Obstructive Sleep Apnea, Obesity
190 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are ASA physical status I, II, or III.
You are 35 kg/m2 or greater and/or documented or suspected Obstructive Sleep Apnea.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.