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

Not Applicable

Recruiting

• Conditions: Anaesthesia; endoscopic retrograde cholangiopancreatography; Airway management; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Respiratory - Normal development and function of the respiratory system; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12619000397112
• Lead Sponsor: The Queen Elizabeth Hopsital Anaesthesia Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Adults (aged over 18 years) fulfilling any of these criteria: ASA 3, or 4, obesity (BMI above 30 kg/m2), obstructive sleep apnoea diagnosed by polysomnography, being treated with CPAP for OSA, or suspected OSA based on STOP BANG greater than or equal to 3

Exclusion Criteria

1.Deemed difficult airway” and/or difficult intubation based on clinical judgement and known previous difficult airway.
2.Severe cardio-respiratory compromise or any other indications that warrant the procedure to be done under general anaesthesia with endotracheal tube.
3.Patients judged at significant risk of pulmonary aspiration. Risk assessment will be based on patient history (focussing particularly on risk factors for aspiration) and physical examination. Possible risk factors for aspiration include:
a)Increased gastric content, delayed gastric emptying, including lap band in situ, lack of fasting (less than six hours’ solids and two hours for clear fluid).
b)Increased regurgitation risk: Uncontrolled or symptomatic gastro-oesophageal reflux, oesophageal strictures, Zenker Diverticulum and achalasia.
c)Laryngeal incompetence: may be due to cerebral infarct, head injuries, neuromuscular disorders (Parkinson’s disease, Gullian Barre), muscular dystrophies (cerebral palsy, cranial neuropathies).
4.Emergency surgery and any other criteria warranting general anaesthesia with ETT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of hypoxia, defined by any event of SpO2 <90%: Proportion of patients experiencing desaturation below 90% <br>Assessed by pulse oximetry[During the course of the anaesthetic]