Patient Population Submitted to ERCP
Conditions
Keywords
ERCP, High Flow nasal cannula, deep sedation
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).
Interventions
DEVICEHigh Flow nasal cannula
Administration of high flow nasal cannula during ERCP procedure
DEVICELow Flow nasal cannula
Administration of low flow nasal cannula during ERCP procedure: standard care
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients Age over ≥18 years. Willing to participate
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| CO2 during ERCP | 2 years | The use of HF decreases the CO2 levels measured through transcutaneous CO2 (PtcCO2) compared to conventional oxygen therapy (LF) |
Countries
Spain
Contacts
Primary ContactJulia Martinez Ocon, Dr
Outcome results
None listed