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

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

The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.

Participants will be randomized to 3 groups: G0 will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1 will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.

Study Overview

• Status: Completed
• Conditions: High-flow Nasal Cannula; Intravenous Sedation
• Intervention / Treatment: Device: High flow nasal cannula (15 L/m); Device: High flow nasal cannula (30 L/m); Device: High flow nasal cannula (60 L/m)

Detailed Description

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.

The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.

A total of 60 patients undergoing ERCP will be equally randomized to 3 groups:

G0: will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1: will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.

The three groups' intra-procedure and outcome parameters and variables will be compared. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p<0.05. ANOVA test will be performed to compare the different means between the four groups. Minimum and maximum 3 of 17 values will be recorded for each value in all 3 groups. A two sided P value of less than 0.05 will be considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Christian Rouphael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; High flow rate of 5 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 15 liter; Nasal cannula at flow rate of 15 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 60 liter; 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturation	Desaturation (SpO2≤95%) or a drop of more than 5% from baseline SpO2	During the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest SpO2	Lowest SpO2 (%)	During procedure
Mean SpO2	Mean SpO2 (%)	During procedure
Duration of the procedure	Duration of the procedure measured in minutes	During procedure
Snoring status	Snoring status measured as Yes/No	During procedure
Snoring snore	snoring score assessed using a subjective snoring classification developed at Stanford on a scale from 0 to 10	During procedure
Gastroenterologists' satisfaction	Gastroenterologists' satisfaction measured using a 5-point Likert scale	During procedure
Patients' satisfaction	Patients' satisfaction measured using a 5-point Likert scale	During procedure

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Christian Rouphael, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): March 17, 2025
• Study Completion (Actual): March 17, 2025

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ANES.CE.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No