Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS (SuperNo2VA)

Comparison of Oxygenation Between Nasal Positive Airway Pressure (PAP) Versus Standard Care During Propofol-based Sedation for Endoscopic Ultrasound in an Ambulatory Surgical Setting: a Prospective Randomized Control Trial

Randomized controlled single site study involves oxygenation, continuous positive airway pressure, and ventilation of subject via nasal mask and oxygenationvia closed facemask. The intervention of the study are delivery form of supplemental oxygen, bag-mask ventilation, and continuous nasal CPAP intraoperatively and in the post anesthesia care period.

Study Overview

• Status: Terminated
• Conditions: Endoscopic Ultrasound
• Intervention / Treatment: Device: SuperNO2VA

Detailed Description

124 patients with BMI> or equal to 35kg.m2 or documented Obstructive Sleep Apnea scheduled for an EUS with Propofol sedation will be randomized to CPAP vs nasal mask for oxygenation during their procedure. Patients will be monitored every 2 minutes during the procedure and in the recovery area until discharge. If patients have difficulty or refuse to wear the mask, 2 or more simultaneous or non-synchronous adverse events, change in heart rhythm or ST changes on EKG they will immediately changed to the other group. The ansethesiologist, gastroenterologist & patient will complete post-procedure questionnaires regarding their opinion of the oxygen delivery system.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5121
      • Indiana University Hospital
    • Indianapolis, Indiana, United States, 46202-5121
      • Indiana University Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years of age or older
2. Patients undergoing upper endoscopic ultrasound
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea
5. Has provided written informed consent

Exclusion Criteria:

1. Inpatient status
2. Active Congestive Heart Failure Exacerbation
3. Untreated ischemic heart disease
4. Acute exacerbation of respiratory disorders, including COPD and asthma
5. Emergent procedures
6. Pregnancy
7. Previous enrollment in this study
8. Inability to provide informed consent
9. Additional medical testing planned for the same day
10. History of allergic reaction to Propofol
11. Tracheostomy
12. Supra-glottic or sub-glottic tumor
13. Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Facial mask; facial mask for oxygen delivery	Device: SuperNO2VA; SUPERNO2VA is nasal PAP device for oxygen delivery
EXPERIMENTAL: SuperNO2VA; SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask	Device: SuperNO2VA; SUPERNO2VA is nasal PAP device for oxygen delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benefit of Nasal PAP Versus Nasal Administration of Oxygen	Compare the incidence, duration, and severity of oxygen desaturation	60 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Amount of Propofol for Adequate Sedation	Compares amounts of Propofol for induction and entire procedure	60 minutes.
Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)	Compare MOAAS immediately prior to intubation and during procedure	120 minutes
Procedural Interruptions	Compare incidence, duration and reason for procedural interruptions	60 minutes

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Vyaire Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2020
• Primary Completion (ACTUAL): March 30, 2022
• Study Completion (ACTUAL): March 30, 2022

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1810997768

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