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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea, Obesity
• Interventions: Device: Standard care with a facemask.; Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

• Registration Number: NCT05524220
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-09-01
• Study Start: 2022-12-19
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-09
• Results First Submitted: 2024-08-07
• Results First Submitted QC: 2025-02-12
• Results First Posted: 2025-03-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Standard care with a facemask.	Standard care with a facemask.	-
Group B: SuperNO2VA™EtCO2	SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)	-

Primary Outcome Measures

Name	Time	Method
Time Taken From Initiation of Induction to the First Airway Intervention	From Initiation of Induction to the First Airway Intervention (about 16 minutes)

Secondary Outcome Measures

Name	Time	Method
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	This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness
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)
Time Taken for Airway Maneuvers	From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Reason for Airway Maneuvers	From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken From Induction to Endoscopic Insertion	within 10 minutes of start of sedation
Number of Participants Who Received Airway Maneuvers	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	From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken for the Entire Procedure	from start of procedure to end of procedure (about 45 minutes)
Recovery Time as Assessed by the Time When Subject Was Ready for Discharge	at time of discharge( about one hour from end of procedure)
Recovery Time as Assessed by the Actual Time When Subject Was Discharged	at time of discharge( about one and a half hour from end of procedure)
Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)	at time of discharge(about one hour from end of procedure)	This will be scored from 0-10, a higher score indicating more satisfaction
Number of Participants That Tolerated the SuperNO2VA™EtCO2	from start of procedure to end of procedure (about 45 minutes)
Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)	end of procedure (about 45 minutes from start)	This will be scored from 0-10, a higher score indicating more satisfaction
Number of Participants That Had Incidences of Cardiac Complications	during the procedure (about 45 minutes)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States