Clinical trial NCT04082208: High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) HF-study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Population Submitted to ERCP
Keywords: ERCP
High Flow nasal cannula
deep sedation
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* Patients Age over ≥18 years. Willing to participate

Exclusion Criteria:

* None

Primary outcomes:
measure: Desaturation during ERCP
timeFrame: 2 years
Secondary outcomes:
measure: CO2 during ERCP
timeFrame: 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinic Hospital (Endoscopy Unit)
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Julia Martinez Ocon, Dr
role: PRINCIPAL_INVESTIGATOR
References: