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

NCT04184089 | Completed

• 1 other identifier: ANES.CE.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

High-flow Nasal Cannula; Intravenous Sedation

Outcome Measures

Primary Outcomes (1)

• Desaturation

  Desaturation (SpO2≤95%) or a drop of more than 5% from baseline SpO2

  During the surgery

Secondary Outcomes (7)

• Lowest SpO2

  During procedure

• Mean SpO2

  During procedure

• Duration of the procedure

  During procedure

• Snoring status

  During procedure

• Snoring snore

  During procedure

Study Arms (3)

Control group

EXPERIMENTAL

High flow rate of 5 L/min and FiO2 of 40%

Device: High flow nasal cannula (15 L/m)

Group 15 liter

EXPERIMENTAL

Nasal cannula at flow rate of 15 L/min and FiO2 of 40%

Device: High flow nasal cannula (30 L/m)

Group 60 liter

EXPERIMENTAL

Nasal cannula at flow rate of 60 L/min and FiO2 of 40%

Device: High flow nasal cannula (60 L/m)

Interventions

High flow nasal cannula (30 L/m) DEVICE

nasal cannula at a flow rate of 30l/min and FiO2 of 40%

Group 15 liter

High flow nasal cannula (60 L/m) DEVICE

nasal cannula at flow rate of 60L/min. Oxygen supplementation will be at an FiO2 of 40%.

Group 60 liter

High flow nasal cannula (15 L/m) DEVICE

nasal cannula at a flow rate of 15 l/min and FiO2 of 40%

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

Christian Rouphael

Beirut, Lebanon

Location

Study Officials

• Christian Rouphael, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Clinical Specialty

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: December 3, 2019
• Study Start: August 25, 2020
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

LE (1)