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OpenTrials
Completed

NCT Number: NCT03028688

HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High flow nasal cannula oxygen

Device

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

Primary outcomes

  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 analyzed by time to event.

Secondary outcomes

  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 analyzed by time to event.

  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 25% below baseline value any time during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Anesthesia Patient Safety Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2017
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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