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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082208
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
JULIA MARTÍNEZ OCÓN, 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).

Condition or disease Intervention/treatment Phase
Patient Population Submitted to ERCP Device: High Flow nasal cannula Device: Low Flow nasal cannula Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients Age over ≥18 years. Willing to participate

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Julia Martinez Ocon, Dr +34639987302 jocon@clinic.cat

Locations
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Spain
Clinic Hospital (Endoscopy Unit) Recruiting
Barcelona, Spain, 08036
Contact: JULIA MARTINEZ, dr    +34932275558 ext 5558    jocon@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Julia Martinez Ocon, Dr Hospital Clinic of Barcelona
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Responsible Party: JULIA MARTÍNEZ OCÓN, Anesthesiologist, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04082208    
Other Study ID Numbers: High-Flow study-172
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by JULIA MARTÍNEZ OCÓN, Hospital Clinic of Barcelona:
ERCP
High Flow nasal cannula
deep sedation