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

Indiana University

Status: Terminated

Conditions: Endoscopic Ultrasound

Treatments: Device: SuperNO2VA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04306211

1810997768

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Facial mask

Active Comparator group

Description:

facial mask for oxygen delivery

Treatment:

Device: SuperNO2VA

SuperNO2VA

Experimental group

Description:

SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask

Treatment:

Device: SuperNO2VA