HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03028688|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : October 10, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Michael Mazzeffi, MD MPHfirstname.lastname@example.org|
|Contact: Kendra Petrickemail@example.com|
|United States, Maryland|
|University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Michael A Mazzeffi, MD MPH 504-232-0242 firstname.lastname@example.org|
|Contact: LaToya Stubbs, BS 410-328-9951 email@example.com|
|Principal Investigator:||Michael A Mazzeffi, MD MPH||University of Maryland|