High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography With Intravenous Sedation.

Sponsor

American University of Beirut Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04184089

Collaborator

(none)

Enrollment

Location

Arms

26.2

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

High flow nasal cannula provides adequate oxygenation in patients with compromised pulmonary function. Very few studies in the literature addressed its use with IV sedation in the OR. Successful application of High Flow nasal cannula in intravenous deep sedation cases in the OR will benefit in the reduction of airway manipulation and side effects from general anesthesia.

This study aims to find out the optimal nasal cannula flow rate for maintenance of safe IV deep sedation in endoscopic retrograde cholangiopancreatography (ERCP) patients and to assess gastroenterologist and patient satisfaction.

Condition or Disease	Intervention/Treatment	Phase
High-flow Nasal Cannula Intravenous Sedation	Device: High flow nasal cannula (15 L/m) Device: High flow nasal cannula (30 L/m) Device: High flow nasal cannula (60 L/m)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography With Intravenous Sedation.

Actual Study Start Date :

Aug 25, 2020

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group High flow rate of 5 L/min and FiO2 of 40%
Experimental: Group 1 Nasal cannula at flow rate of 15 L/min and FiO2 of 40%	Device: High flow nasal cannula (15 L/m) nasal cannula at a flow rate of 15 l/min and FiO2 of 40%
Experimental: Group 2 Nasal cannula at flow rate of 30 L/min and FiO2 of 40%	Device: High flow nasal cannula (30 L/m) nasal cannula at a flow rate of 30l/min and FiO2 of 40%
Experimental: Group 3 Nasal cannula at flow rate of 60 L/min and FiO2 of 40%	Device: High flow nasal cannula (60 L/m) nasal cannula at flow rate of 60L/min. Oxygen supplementation will be at an FiO2 of 40%.

Outcome Measures

Primary Outcome Measures

Optimal flow rate [During the surgery]
The optimal flow rate stabilized for the patient which is determined by the oxygen saturation (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patient able to give consent.
Patient undergoing deep sedation.
Patient undergoing ERCP procedure with no restrictions on the duration of the procedure.
Age > 18 years
Patients with BMI < 40 kg/m2

Exclusion Criteria:

Patient unable to give consent
Patient refusal to participate
Patients undergoing general anesthesia
age less than 18 years old
Patients with severe heart failure (EF<30%)
Morbidly obese Patients with BMI > 40 kg/m2
Patients with sleep apnea
Claustrophobia
Risk of aspiration due to severe reflux
Facial injury, facial malformation
Nasal defects/obstruction
ASA 4 patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christine El-Yahchouchi	Beirut		Lebanon

Sponsors and Collaborators

American University of Beirut Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christine El Yahchouchi, Instructor of Clinical Specialty, American University of Beirut Medical Center

ClinicalTrials.gov Identifier:

NCT04184089

Other Study ID Numbers:

ANES.CE.01

First Posted:

Dec 3, 2019

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 1, 2021