Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction

April 3, 2025 updated by: Erikka L Washington, The University of Texas Health Science Center, Houston

Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing colonoscopy
  • American Society of Anesthesiology (ASA) Physical Status I-III
  • BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea

Exclusion Criteria:

  • Inpatient status
  • Active Congestive Heart Failure Exacerbation
  • Untreated ischemic heart disease
  • Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
  • Emergent procedures
  • Pregnancy
  • Previous enrollment in this study
  • Inability to provide informed consent
  • Additional medical testing planned for the same day
  • History of allergic reaction to Propofol
  • Tracheostomy
  • Supra-glottic or sub-glottic tumor
  • Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
  • Prisoners
  • Unable to fit SuperNoVa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A: Standard care with a facemask.
Device: Standard care with a facemask.
The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
Experimental: Group B: SuperNO2VA™EtCO2
Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time Taken From Initiation of Induction to the First Airway Intervention
Time Frame: From Initiation of Induction to the First Airway Intervention (about 16 minutes)
From Initiation of Induction to the First Airway Intervention (about 16 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amount of Propofol Administered During Induction
Time Frame: Within 5 minutes of the start of anesthesia
Within 5 minutes of the start of anesthesia
Total Amount of Propofol Administered During the Procedure
Time Frame: during the procedure (about 45 minutes)
during the procedure (about 45 minutes)
Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)
Time Frame: prior to endoscopic intubation,during the procedure
This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness
prior to endoscopic intubation,during the procedure
Time Taken From Induction to Endoscopic Insertion
Time Frame: within 10 minutes of start of sedation
within 10 minutes of start of sedation
Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient
Time Frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient
Time Frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Number of Participants Who Received Airway Maneuvers
Time Frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken for Airway Maneuvers
Time Frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Reason for Airway Maneuvers
Time Frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken for the Entire Procedure
Time Frame: from start of procedure to end of procedure (about 45 minutes)
from start of procedure to end of procedure (about 45 minutes)
Recovery Time as Assessed by the Time When Subject Was Ready for Discharge
Time Frame: at time of discharge( about one hour from end of procedure)
at time of discharge( about one hour from end of procedure)
Recovery Time as Assessed by the Actual Time When Subject Was Discharged
Time Frame: at time of discharge( about one and a half hour from end of procedure)
at time of discharge( about one and a half hour from end of procedure)
Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)
Time Frame: at time of discharge(about one hour from end of procedure)
This will be scored from 0-10, a higher score indicating more satisfaction
at time of discharge(about one hour from end of procedure)
Number of Participants That Tolerated the SuperNO2VA™EtCO2
Time Frame: from start of procedure to end of procedure (about 45 minutes)
from start of procedure to end of procedure (about 45 minutes)
Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)
Time Frame: end of procedure (about 45 minutes from start)
This will be scored from 0-10, a higher score indicating more satisfaction
end of procedure (about 45 minutes from start)
Number of Participants That Had Incidences of Cardiac Complications
Time Frame: during the procedure (about 45 minutes)
during the procedure (about 45 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vyaire Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erikka Washington, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-22-0351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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