ClinicalTrials.Veeva

Menu

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

Indiana University logo

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

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

Trial documents
2

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems