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

Patient Population Submitted to ERCP Clinical Trial

— HFS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04082208
• Other study ID #: High-Flow study-172
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2020
• Source: Hospital Clinic of Barcelona
• Contact: Julia Martinez Ocon, Dr
• Phone: +34639987302
• Email: jocon[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients Age over =18 years. Willing to participate

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Patient Population Submitted to ERCP

Intervention

Device:
• High Flow nasal cannula
Administration of high flow nasal cannula during ERCP procedure
• Low Flow nasal cannula
Administration of low flow nasal cannula during ERCP procedure: standard care

Locations

Country	Name	City	State
Spain	Clinic Hospital (Endoscopy Unit)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CO2 during ERCP	The use of HF decreases the CO2 levels measured through transcutaneous CO2 (PtcCO2) compared to conventional oxygen therapy (LF)	2 years