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

Not Applicable

Terminated

• Conditions: Endoscopic Ultrasound
• Interventions: Device: SuperNO2VA

• Registration Number: NCT04306211
• Lead Sponsor: Indiana University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Study Start: 2020-12-14
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Results First Submitted: 2022-04-06
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-07
• Last Update Submitted: 2022-10-07
• Results First Posted: 2022-11-03
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Facial mask	SuperNO2VA	facial mask for oxygen delivery
SuperNO2VA	SuperNO2VA	SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask

Primary Outcome Measures

Name	Time	Method
Benefit of Nasal PAP Versus Nasal Administration of Oxygen	60 minutes.	Compare the incidence, duration, and severity of oxygen desaturation

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States