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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000397112

Enrollment

Registered

2019-03-12

Start date

2019-02-04

Completion date

2021-08-01

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results