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

Endoscopic Ultrasound Clinical Trial

— SuperNo2VA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04306211
• Other study ID #: 1810997768
• Status: Terminated
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: October 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Endoscopic Ultrasound

Intervention

Device:
• SuperNO2VA
SUPERNO2VA is nasal PAP device for oxygen delivery

Locations

Country	Name	City	State
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Vyaire Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benefit of Nasal PAP Versus Nasal Administration of Oxygen	Compare the incidence, duration, and severity of oxygen desaturation	60 minutes.
Secondary	Total Amount of Propofol for Adequate Sedation	Compares amounts of Propofol for induction and entire procedure	60 minutes.
Secondary	Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)	Compare MOAAS immediately prior to intubation and during procedure	120 minutes
Secondary	Procedural Interruptions	Compare incidence, duration and reason for procedural interruptions	60 minutes