HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT03028688

Collaborator

Anesthesia Patient Safety Foundation (Other)

262

Enrollment

Location

Arms

22.6

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a risk for low oxygen saturation during the procedure, which presents a significant patient safety issue. The purpose of the clinical trial is compare the current anesthesia standard of care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Morbidity	Device: High flow nasal cannula oxygen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

262 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

HIFLO ENDO- Use of High Flow Nasal Cannula Oxygenation to Increase Patient Safety During Upper GI Endoscopy

Actual Study Start Date :

Jun 21, 2017

Actual Primary Completion Date :

May 9, 2019

Actual Study Completion Date :

May 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Current standard of care Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed.
Experimental: High flow nasal cannula group Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed.	Device: High flow nasal cannula oxygen Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.

Arm

Intervention/Treatment

No Intervention: Current standard of care

Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed.

Experimental: High flow nasal cannula group

Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed.

Device: High flow nasal cannula oxygen

Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.

Outcome Measures

Primary Outcome Measures

Hypoxemia event (Low blood oxygen level) [The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.]
The primary outcome measure will be occurrence of a low blood oxygen level defined by oxygen saturation less than 92% for greater than 15 seconds at any point during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.

Secondary Outcome Measures

Hypercarbia event (Elevated blood CO2 level) [The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.]
The secondary outcome measure will be occurrence of an elevated blood carbon dioxide level defined as 20 mmHg above the patient's baseline value at any time during their anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
Hypotension event (Low blood pressure) [The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.]
The secondary outcome measure will occurrence of low blood pressure defined as blood pressure 25% below baseline value any time during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.
Age greater than or equal to 18 years

Exclusion Criteria:

Propofol, midazolam, or fentanyl allergy
Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion of the attending anesthesiologist)
Any procedure with planned electro-cautery as a high-inspired oxygen concentration could increase the risk for airway or esophageal fire.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

University of Maryland, Baltimore
Anesthesia Patient Safety Foundation

Investigators

Principal Investigator: Michael A Mazzeffi, MD MPH, University of Maryland School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Mazzeffi, Assistant Professor of Anesthesiology, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT03028688

Other Study ID Numbers:

HP-00071111

First Posted:

Jan 23, 2017

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 21, 2022