HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

Anesthesia Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028688
• Other study ID #: HP-00071111
• Status: Completed
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: May 9, 2019

Study information

• Verified date: July 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia Morbidity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Anesthesia Patient Safety Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia event (Low blood oxygen level)	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.	The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
Secondary	Hypercarbia event (Elevated blood CO2 level)	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.	The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
Secondary	Hypotension event (Low blood pressure)	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.	The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.