Clinical trial NCT04306211: Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endoscopic Ultrasound
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Vyaire Medical
First posted: 2020-03-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Benefit of Nasal PAP Versus Nasal Administration of Oxygen
timeFrame: 60 minutes.
Secondary outcomes:
measure: Total Amount of Propofol for Adequate Sedation
timeFrame: 60 minutes.
measure: Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)
timeFrame: 120 minutes
measure: Procedural Interruptions
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: John M DeWitt, MD
role: PRINCIPAL_INVESTIGATOR
References: