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

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

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erikka Washington, MD; Phone Number: (713) 500-6202; Email: Erikka.L.Washington@uth.tmc.edu
• Study Contact Backup: Name: Ranganathan Govindaraj; Phone Number: 713-500-6200; Email: Ranganathan.Govindaraj@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Ranganathan Govindaraj; Phone Number: 713-500-6200; Email: Ranganathan.Govindaraj@uth.tmc.edu
      • Contact: Erikka Washington, MD; Phone Number: 713-500-6202; Email: Erikka.L.Washington@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• 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 ≥35 kg/m2 and/or documented 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Time taken from initiation of induction to the first airway intervention	end of endoscopy procedure( about 45 minutes form start of procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of propofol administered during induction		Within 5 minutes of the start of anesthesia
Total amount of propofol administered during the procedure		end of procedure (about 45 minutes after start)
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	prior to endoscopic intubation,during the procedure
Time taken from induction to endoscopic insertion		within 5 minutes of start of sedation
Incidence of procedural interruptions as assessed by the number of times the endoscope is removed from the patient		end of procedure (about 45 minutes form start)
Duration of procedural interruptions as assessed by the length of time the endoscope is removed from the patient		end of procedure (about 45 minutes form start)
Number of participants who received airway maneuvers		end of procedure (about 45 minutes form start)
Time taken for airway maneuvers		end of procedure (about 45 minutes form start)
Reason for airway maneuvers		end of procedure (about 45 minutes form start)
Time taken for the entire procedure		end of procedure (about 45 minutes form start)
Recovery time as assessed by the time when subject was ready for discharge		at time of discharge( about one hour form end of procedure)
Recovery time as assessed by the actual time when subject was discharged		at time of discharge( about one hour form end of procedure)
Patient satisfaction as assessed by the visual analog scale (VAS)	This will be scored from 0-10, a higher score indicating more satisfaction	at time of discharge(about one hour form 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)	This will be scored from 0-10, a higher score indicating more satisfaction	end of procedure
Number of participants that had incidences of cardiac complications		from start of procedure to end of procedure (about 45 minutes)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Vyaire Medical
• Investigators: Principal Investigator: Erikka Washington, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): August 9, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: obesity; Obstructive Sleep Apnea; colonoscopy; total IV anesthesia; Nasal cpap
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Respiratory Insufficiency; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Airway Obstruction
• Other Study ID 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