High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) HF-study

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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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

Conditions
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Patient Population Submitted to ERCP

Intervention / Treatment
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* Device: High Flow nasal cannula
* Device: Low Flow nasal cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients Age over ≥18 years. Willing to participate Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>High Flow nasal cannula (HF) | Device: High Flow nasal cannula<br>* Administration of high flow nasal cannula during ERCP procedure<br>|
| Active Comparator: Standar Care Group<br>Standar Care: low flow device (LF) | Device: Low Flow nasal cannula<br>* Administration of low flow nasal cannula during ERCP procedure: standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desaturation during ERCP | 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). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CO2 during ERCP | The use of HF decreases the CO2 levels measured through transcutaneous CO2 (PtcCO2) compared to conventional oxygen therapy (LF) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, High Flow nasal cannula, deep sedation