High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) HF-study (HFS)
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|ClinicalTrials.gov Identifier: NCT04082208|
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Patient Population Submitted to ERCP||Device: High Flow nasal cannula Device: Low Flow nasal cannula||Not Applicable|
Deep sedation performed during the ERCP technique associates an increased risk of decrease in Sat02%, hypercapnia and airway obstruction with consequences ranging from interruption or suspension of the technique to complications that may put the patient's life at risk .
High flow devices (HF) due to the pressurization capacity of the airway and the reduction of anatomical dead space will favor a better gas exchange compared to low flow devices (LF), which will manifest clinically with a reduction in episodes of decrease of Sat02% and a decrease in carbon dioxide levels.
The main objective of the study is to demonstrate that the use of high flow devices (HF) decreases the episodes of desaturation (defined as Sat02 ≤ 90% measured through pulse oximetry) that occur during the performance of ERCP under deep sedation compared to Low flow devices (LF) with equal Inspiratory oxygen fraction (Fi02) in both cases.
The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Unicentre controlled clinical trial, unmasked, performed in the Digestive Endoscopy Unit of the Hospital Clínic. 172 patients submitted to Endoscopic Retrograde Cholangiography who agree to participate in the study will be included consecutively and randomly.
Patients will be randomized into two groups: Control group: low flow device (nasal glasses) and High Flow device group (LAF).
|Masking:||None (Open Label)|
|Official Title:||Use of High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) Under Sedation. Comparative, Randomized Study of Two Health Products Approved by the Community|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: Intervention Group
High Flow nasal cannula (HF)
Device: High Flow nasal cannula
Administration of high flow nasal cannula during ERCP procedure
Active Comparator: Standar Care Group
Standar Care: low flow device (LF)
Device: Low Flow nasal cannula
Administration of low flow nasal cannula during ERCP procedure: standard care
- Desaturation during ERCP [ Time Frame: 2 years ]Demonstrate that the use of high flow devices (HF) decreases episodes of desaturation (defined as Sat02 ≤ 90% measured by pulse oximetry) that occur during the performance of ERCP under deep sedation compared to low flow devices ( LF).
- CO2 during ERCP [ Time Frame: 2 years ]The use of HF decreases the CO2 levels measured through transcutaneous CO2 (PtcCO2) compared to conventional oxygen therapy (LF)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082208
|Contact: Julia Martinez Ocon, Dremail@example.com|
|Clinic Hospital (Endoscopy Unit)||Recruiting|
|Barcelona, Spain, 08036|
|Contact: JULIA MARTINEZ, dr +34932275558 ext 5558 firstname.lastname@example.org|
|Principal Investigator:||Julia Martinez Ocon, Dr||Hospital Clinic of Barcelona|