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

NCT05524220 | Completed Results FDA Device

• 1 other identifier: HSC-MS-22-0351
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obstructive Sleep Apnea, Obesity

Keywords

Obstructive Sleep Apnea; total IV anesthesia; obesity; colonoscopy; Nasal cpap

Outcome Measures

Primary Outcomes (1)

• Time Taken From Initiation of Induction to the First Airway Intervention

  From Initiation of Induction to the First Airway Intervention (about 16 minutes)

Secondary Outcomes (16)

• Amount of Propofol Administered During Induction

  Within 5 minutes of the start of anesthesia

• Total Amount of Propofol Administered During the Procedure

  during the procedure (about 45 minutes)

• Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)

  prior to endoscopic intubation,during the procedure

• Time Taken From Induction to Endoscopic Insertion

  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

  From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)

Study Arms (2)

Group A: Standard care with a facemask.

ACTIVE COMPARATOR

Device: Standard care with a facemask.

Group B: SuperNO2VA™EtCO2

EXPERIMENTAL

Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

Interventions

Standard care with a facemask. DEVICE

The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)

Group A: Standard care with a facemask.

SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) DEVICE

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)

Group B: SuperNO2VA™EtCO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Vyaire Medical: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Erikka Washington, MD
• Organization: The University of Texas Health Science Center at Houston

Erikka.L.Washington@uth.tmc.edu

713-500-6202

Study Officials

• Erikka Washington, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: December 19, 2022
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: April 22, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)