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

NCT04306211 | Terminated Results DMC FDA Device

• 1 other identifier: 1810997768
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Endoscopic Ultrasound

Outcome Measures

Primary Outcomes (1)

• Benefit of Nasal PAP Versus Nasal Administration of Oxygen

  Compare the incidence, duration, and severity of oxygen desaturation

  60 minutes.

Secondary Outcomes (3)

• Total Amount of Propofol for Adequate Sedation

  60 minutes.

• Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)

  120 minutes

• Procedural Interruptions

  60 minutes

Study Arms (2)

Facial mask

ACTIVE COMPARATOR

facial mask for oxygen delivery

Device: SuperNO2VA

SuperNO2VA

EXPERIMENTAL

SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask

Device: SuperNO2VA

Interventions

SuperNO2VA DEVICE

SUPERNO2VA is nasal PAP device for oxygen delivery

Facial mask; SuperNO2VA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indiana University: lead
• Vyaire Medical: collaborator

Study Sites (2)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

Results Point of Contact

• Title: John M. DeWitt, MD
• Organization: Indiana University

jodewitt@iu.edu

317-944-0980

Study Officials

• John M DeWitt, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 12, 2020
• Study Start: December 14, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: November 3, 2022
• Results First Posted: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)