Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

NCT03369197 | Completed Results FDA Device

• 1 other identifier: IRB00118466
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.

Conditions

Hypoxia; Endoscopy; Anesthesia Morbidity

Keywords

procedural sedation; monitored anesthesia care; endoscopy

Outcome Measures

Primary Outcomes (1)

• Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event

  Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.

  Approximately 1 hour

Secondary Outcomes (6)

• Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring

  Approximately 1 hour

• Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring

  Approximately 1 hour

• Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation

  Approximately 1 hour

• Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy

  Approximately 1 hour

• Hypoxia Duration

  Approximately 1 hour

Other Outcomes (1)

• Short Chain Fatty Acid Concentration

  Approximately 1 hour

Study Arms (2)

Intervention: Nasal Mask

EXPERIMENTAL

Nasal anesthesia mask with positive pressure

Device: Nasal Mask

Control: Nasal cannula

ACTIVE COMPARATOR

Nasal Cannula with standard care

Device: Control: Nasal Cannula

Interventions

Nasal Mask DEVICE

Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve

Also known as: Intervention: Nasal anesthesia mask with positive pressure

Intervention: Nasal Mask

Control: Nasal Cannula DEVICE

Nasal cannula as per usual care

Also known as: Standard Care

Control: Nasal cannula

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.

You may not qualify if:

• Left ventricular Assist Device
• Severe Pulmonary Hypertension
• Ejection fraction less than 35 percent
• Active Congestive Heart Failure Exacerbation
• Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.
• Topical lidocaine administration
• Pregnancy
• Previous enrollment in this study

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Laeben Lester
• Organization: The Johns Hopkins University

llester4@jhmi.edu

410-955-7519

Study Officials

• Laeben Lester, MD

  Johns Hopkins School of Medicine

  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: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 11, 2017
• Study Start: October 30, 2017
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: October 18, 2022
• Results First Posted: December 21, 2020

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)