HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

Not Applicable

Completed

• Conditions: Anesthesia Morbidity
• Interventions: Device: High flow nasal cannula oxygen

• Registration Number: NCT03028688
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Study Start: 2017-06-21
• Primary Completion: 2019-05-09
• Study Completion: 2019-05-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States