Skip to main content
OpenTrials
Completed

NCT Number: NCT04184089

High Flow Nasal Cannula in Patients Undergoing ERCP 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%.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

High-flow Nasal Cannula Intravenous Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christian Rouphael

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flow nasal cannula (15 L/m)

Device

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

High flow nasal cannula (30 L/m)

Device

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

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%.

Primary outcomes

  1. Desaturation

    Time frame: During the surgery

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

Secondary outcomes

  1. Lowest SpO2

    Time frame: During procedure

    Lowest SpO2 (%)

  2. Mean SpO2

    Time frame: During procedure

    Mean SpO2 (%)

  3. Duration of the procedure

    Time frame: During procedure

    Duration of the procedure measured in minutes

  4. Snoring status

    Time frame: During procedure

    Snoring status measured as Yes/No

  5. Snoring snore

    Time frame: During procedure

    snoring score assessed using a subjective snoring classification developed at Stanford on a scale from 0 to 10

  6. Gastroenterologists' satisfaction

    Time frame: During procedure

    Gastroenterologists' satisfaction measured using a 5-point Likert scale

  7. Patients' satisfaction

    Time frame: During procedure

    Patients' satisfaction measured using a 5-point Likert scale

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2019
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.