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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endoscopic Ultrasound
- Sponsor
- Indiana University
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Benefit of Nasal PAP Versus Nasal Administration of Oxygen
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
John DeWitt
Associate Professor of Medicine
Indiana University
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Inpatient status
- •Active Congestive Heart Failure Exacerbation
- •Untreated ischemic heart disease
- •Acute exacerbation of respiratory disorders, including COPD and asthma
- •Emergent procedures
- •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
Outcomes
Primary Outcomes
Benefit of Nasal PAP Versus Nasal Administration of Oxygen
Time Frame: 60 minutes.
Compare the incidence, duration, and severity of oxygen desaturation
Secondary Outcomes
- Procedural Interruptions(60 minutes)
- Total Amount of Propofol for Adequate Sedation(60 minutes.)
- Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)(120 minutes)