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 University of Texas Health Science Center, Houston1 site in 1 country139 target enrollmentDecember 19, 2022

ConditionsObstructive Sleep Apnea, Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Sleep Apnea, Obesity
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 139
Locations: 1
Primary Endpoint: Time Taken From Initiation of Induction to the First Airway Intervention
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 19, 2022

End Date

August 9, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Erikka L Washington

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)
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))
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))
Number of Participants That Had Incidences of Cardiac Complications(during the procedure (about 45 minutes))