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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%.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Christian Rouphael
Beirut, Lebanon
Start Date
August 25, 2020
Primary Completion Date
March 17, 2025
Completion Date
March 17, 2025
Last Updated
December 19, 2025
60
ACTUAL participants
High flow nasal cannula (15 L/m)
DEVICE
High flow nasal cannula (30 L/m)
DEVICE
High flow nasal cannula (60 L/m)
DEVICE
Lead Sponsor
American University of Beirut Medical Center
NCT05526534
NCT06375538
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