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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patient Population Submitted to ERCP
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Desaturation during ERCP
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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).
Investigators
JULIA MARTÍNEZ OCÓN
Anesthesiologist
Hospital Clinic of Barcelona
Eligibility Criteria
Inclusion Criteria
- •Patients Age over ≥18 years. Willing to participate
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- CO2 during ERCP(2 years)