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Trial record 16 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Patient Safety"

HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

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ClinicalTrials.gov Identifier: NCT03028688
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Mazzeffi, University of Maryland

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 21, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Hypoxemia event (Low blood oxygen level) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Hypercarbia event (Elevated blood CO2 level) [ Time Frame: 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.

  2. Hypotension event (Low blood pressure) [ Time Frame: 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 20% below baseline value any time during the patient's anesthesia. This will be a dichotomous outcome variable.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028688


Contacts
Contact: Michael Mazzeffi, MD MPH 410-328-4752 mmazzeffi@anes.umm.edu
Contact: Ameche Anazodo aanazodo@stapa.umm.edu

Locations
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Michael A Mazzeffi, MD MPH    504-232-0242    mmazzeffi@som.umaryland.edu   
Contact: LaToya Stubbs, BS    410-328-9951    lstubbs@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Michael A Mazzeffi, MD MPH University of Maryland

Responsible Party: Michael Mazzeffi, Assistant Professor of Anesthesiology, University of Maryland
ClinicalTrials.gov Identifier: NCT03028688     History of Changes
Other Study ID Numbers: HP-00071111
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No