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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

Primary Purpose

Obstructive Sleep Apnea, Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard care with a facemask.

SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea, Obesity focused on measuring Obstructive Sleep Apnea, total IV anesthesia, obesity, colonoscopy, Nasal cpap

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: Standard care with a facemask.

Group B: SuperNO2VA™EtCO2

Arm Description

Outcomes

Primary Outcome Measures

Time taken from initiation of induction to the first airway intervention

Secondary Outcome Measures

Amount of propofol administered during induction

Total amount of propofol administered during the procedure

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 taken from induction to endoscopic insertion

Incidence of procedural interruptions as assessed by the number of times the endoscope is removed from the patient

Duration of procedural interruptions as assessed by the length of time the endoscope is removed from the patient

Number of participants who received airway maneuvers

Time taken for airway maneuvers

Reason for airway maneuvers

Time taken for the entire procedure

Recovery time as assessed by the time when subject was ready for discharge

Recovery time as assessed by the actual time when subject was discharged

Patient satisfaction as assessed by the visual analog scale (VAS)

This will be scored from 0-10, a higher score indicating more satisfaction

Number of participants that tolerated the SuperNO2VA™EtCO2

Anesthesiologist satisfaction score as assessed by the visual analog scale (VAS)

This will be scored from 0-10, a higher score indicating more satisfaction

Number of participants that had incidences of cardiac complications

Full Information

NCT ID

NCT05524220

First Posted

August 29, 2022

Last Updated

January 6, 2023

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Vyaire Medical

1. Study Identification

Unique Protocol Identification Number

NCT05524220

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 19, 2022 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Vyaire Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: Standard care with a facemask.

Arm Type

Active Comparator

Arm Title

Group B: SuperNO2VA™EtCO2

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Standard care with a facemask.

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

Intervention Description

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)

Primary Outcome Measure Information:

Title

Time taken from initiation of induction to the first airway intervention

Time Frame

end of endoscopy procedure( about 45 minutes form start of procedure)

Secondary Outcome Measure Information:

Title

Amount of propofol administered during induction

Time Frame

Within 5 minutes of the start of anesthesia

Title

Total amount of propofol administered during the procedure

Time Frame

end of procedure (about 45 minutes after start)

Title

Change in alertness of subject as assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)

Description

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

Title

Time taken from induction to endoscopic insertion

Time Frame

within 5 minutes of start of sedation

Title

Incidence of procedural interruptions as assessed by the number of times the endoscope is removed from the patient

Time Frame