RecruitingACTRN12619000397112

High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases: A randomised multicentre trial


Sponsor

The Queen Elizabeth Hopsital Anaesthesia Department

Enrollment

132 participants

Start Date

Feb 4, 2019

Study Type

Interventional

Conditions

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is a common intervention in the treatment of biliary and pancreatic diseases, and the demand for ERCP is increasing. There are several difficulties for the anaesthetist to deal with. It is generally performed in a prone or lateral position under moderate to deep sedation or general anaesthesia. The rate of oxygen desaturation could be as high as 11-50%. Both low flow and high flow nasal cannulas are now established ways of delivering oxygen during sedation. It is unclear whether one technique is better than the other. We hypothesis that high flow nasal cannula may provide better oxygen administration and compare these two techniques


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When doctors perform an endoscopic procedure called ERCP — a procedure that uses a camera and X-rays to look at the bile ducts and pancreas — patients receive sedation. During sedation, oxygen levels in the blood can drop, which is a real safety concern. This study compares two ways of giving extra oxygen during sedation: standard low-flow nasal tubes versus high-flow nasal cannula (HFNC), which delivers warm, humidified oxygen at higher rates. The study focuses on patients who are at higher risk of oxygen drops — including those who are obese, have sleep apnoea, or are generally sicker (ASA class 3 or 4). Researchers want to find out if high-flow oxygen delivery keeps blood oxygen levels more stable throughout the procedure. You may be eligible if you are an adult scheduled for ERCP who falls into a higher-risk category (e.g. BMI over 30, sleep apnoea, or significant other health conditions). People with very difficult airways, those requiring a breathing tube and general anaesthesia, or those at high risk of inhaling stomach contents would not be eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

ARM A: High flow nasal cannula, anaesthetist administrating 100% oxygen at a flow rate between 40-70 litres/minute ARM B: Low flow nasal cannula,anaesthetist administrating oxygen at a flow rate betw

ARM A: High flow nasal cannula, anaesthetist administrating 100% oxygen at a flow rate between 40-70 litres/minute ARM B: Low flow nasal cannula,anaesthetist administrating oxygen at a flow rate between 2-4 litres/minute, 30-40 % oxygen Both interventions continue throughout the duration of anaesthesia Haemodynamic parameters such as oxygen saturation and breathing parameters will be assessed


Locations(3)

The Queen Elizabeth Hospital - Woodville

NSW,SA, Australia

The Royal Adelaide Hospital - Adelaide

NSW,SA, Australia

John Hunter Hospital - New Lambton

NSW,SA, Australia

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ACTRN12619000397112


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