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

• Sponsor: Indiana University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04306211
• Collaborator: Vyaire Medical (Industry)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 48.6
• Patients Per Site: 60
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Ultrasound	Device: SuperNO2VA	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
• Masking: Single (Participant)
• Masking Description: Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: Dec 14, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Benefit of nasal PAP versus nasal administration of oxygen [oxygen saturation below 90% for >15 seconds during procedure]

   Compare the incidence, duration, and severity of oxygen desaturation

Secondary Outcome Measures

1. Total amount of Propofol for adequate sedation [Total duration of procedure]

   Compares amounts of Propofol for induction and entire procedure

2. Modified observer's Assessment and Alertness/Sedation Scale (MOAAS) [baseline, during procedure,and immediate post procedure in recovery area]

   Compare MOAAS immediately prior to intubation and during procedure

3. Procedural interruptions [Baseline & duration of procedure]

   Compare incidence, duration and reason for procedural interruptions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Health University Hospital	Indianapolis	Indiana	United States	46202-5121
2	Indiana University Hospital	Indianapolis	Indiana	United States	46202-5121

Sponsors and Collaborators

• Indiana University
• Vyaire Medical

Investigators

• Principal Investigator: john M DeWitt, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John DeWitt, Associate Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT04306211
• Other Study ID Numbers: 1810997768
• First Posted: Mar 12, 2020
• Last Update Posted: Jan 25, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Jan 25, 2022