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

The University of Texas Health Science Center, Houston139 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Obstructive Sleep Apnea, Obesity

Interventions

Standard care with a facemask.DEVICE

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

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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

Time frame: Within 5 minutes of the start of anesthesia

Total Amount of Propofol Administered During the Procedure

Time frame: during the procedure (about 45 minutes)

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

This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness

Time frame: prior to endoscopic intubation,during the procedure

Time Taken From Induction to Endoscopic Insertion

Time frame: 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