Status:
TERMINATED
Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Vyaire Medical
Conditions:
Endoscopic Ultrasound
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 proc...
Eligibility Criteria
Inclusion
- Age 18 years of age or older
- Patients undergoing upper endoscopic ultrasound
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea
- Has provided written informed consent
Exclusion
- Inpatient status
- Active Congestive Heart Failure Exacerbation
- Untreated ischemic heart disease
- Acute exacerbation of respiratory disorders, including COPD and asthma
- Emergent procedures
- Pregnancy
- Previous enrollment in this study
- Inability to provide informed consent
- Additional medical testing planned for the same day
- History of allergic reaction to Propofol
- Tracheostomy
- Supra-glottic or sub-glottic tumor
- Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04306211
Start Date
December 14 2020
End Date
March 30 2022
Last Update
November 3 2022
Active Locations (2)
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1
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202-5121
2
Indiana University Hospital
Indianapolis, Indiana, United States, 46202-5121