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

NCT ID: NCT04184089

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2025-03-17

Brief Summary

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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%.

Detailed Description

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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.

Conditions

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High-flow Nasal Cannula Intravenous Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type EXPERIMENTAL

High flow nasal cannula (15 L/m)

Intervention Type DEVICE

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

Group 15 liter

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

Group Type EXPERIMENTAL

High flow nasal cannula (30 L/m)

Intervention Type DEVICE

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

Group 60 liter

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

Group Type EXPERIMENTAL

High flow nasal cannula (60 L/m)

Intervention Type DEVICE

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

Interventions

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High flow nasal cannula (15 L/m)

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

Intervention Type DEVICE

High flow nasal cannula (30 L/m)

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

Intervention Type 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%.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christian Rouphael

Instructor of Clinical Specialty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Rouphael, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

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Christian Rouphael

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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ANES.CE.01

Identifier Type: -

Identifier Source: org_study_id