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

Not Applicable

• Conditions: Patient Population Submitted to ERCP
• Interventions: Device: Low Flow nasal cannula; Device: High Flow nasal cannula

• Registration Number: NCT04082208
• Lead Sponsor: Hospital Clinic of Barcelona

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).

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Status Verified: 2020-02
• Study Start: 2020-02-01
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Patients Age over ≥18 years. Willing to participate

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standar Care Group	Low Flow nasal cannula	Standar Care: low flow device (LF)
Intervention Group	High Flow nasal cannula	High Flow nasal cannula (HF)

Primary Outcome Measures

Name	Time	Method
Desaturation during ERCP	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 Outcome Measures

Name	Time	Method
CO2 during ERCP	2 years	The use of HF decreases the CO2 levels measured through transcutaneous CO2 (PtcCO2) compared to conventional oxygen therapy (LF)

Trial Locations

Locations (1)

Clinic Hospital (Endoscopy Unit); 🇪🇸 Barcelona, Spain