RecruitingACTRN12624000867594

Comparing the effectiveness of using Optiflow Switch vs standard facemask during anaesthesia induction: a randomized controlled trial

Comparing the effectiveness of using Optiflow Switch vs standard facemask during anaesthesia induction in adults: a randomized controlled trial


Sponsor

Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital

Enrollment

50 participants

Start Date

Apr 8, 2025

Study Type

Interventional

Conditions

Summary

In this study, we plan to compare two techniques of supplying oxygen to patients during general anaesthetic induction for surgery. The usual way of doing this procedure involves patient breathing about 10L/min oxygen through a standard facemask before being induced. Once the patient is asleep, the anaesthetist helps bag-mask ventilate the patient via the facemask while waiting for complete muscle relaxation for the intubation. During intubation, the facemask is removed. In this study, a computer program will randomly allocate patients to receive oxygen via one of the two devices: 1) Optiflow Switch or 2) standard facemask. The Optiflow Switch is a relatively new device, which can deliver oxygen at a very high flow rate (up to 70L/min) via two prongs in the nose. It also allows seamless transition to facemask ventilation by diverting nasal oxygen flow away from the patient when a facemask is applied on top of the nasal apparatus. Therefore, for the Optiflow Switch group, patients will receive high flow oxygen through the nasal prongs before going to sleep and during intubation, but bag-mask ventilation in between while waiting for complete muscle paralysis. The study aims to test if the Optiflow Switch provides a higher oxygen level compared to standard facemask when used during anaesthesia induction.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When patients go under general anaesthesia, maintaining safe oxygen levels during the period between losing consciousness and being intubated (having a breathing tube placed) is critically important. A device called Optiflow Switch delivers high-flow oxygen through small nasal prongs and is designed to extend this safe window by continuously oxygenating the patient even when the face mask is temporarily removed. This study is comparing the Optiflow Switch to a standard face mask for delivering oxygen during anaesthesia induction. Patients will be randomly assigned to one of the two approaches, and oxygen levels will be tracked via an arterial line. Researchers want to find out whether the Optiflow Switch keeps oxygen levels higher during this critical window. You may be eligible if you are an adult aged 18 or older who is scheduled for surgery requiring general anaesthesia with an oral breathing tube (intubation), and who needs an arterial line inserted before the operation. People with a known difficult airway, nasal bleeding, aspiration risk, or allergy to propofol or rocuronium would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will receive high flow nasal oxygen therapy through the Optiflow Switch device during anaesthetic induction. High flow nasal oxygen at 30L/min for 30 seconds and then increased to 40L/min

Participants will receive high flow nasal oxygen therapy through the Optiflow Switch device during anaesthetic induction. High flow nasal oxygen at 30L/min for 30 seconds and then increased to 40L/min will be provided during pre-oxygenation before induction. Patient will be asked to breath through the nose with the mouth closed. After 3 minutes of pre-oxygenation, high flow oxygen flow rate is then increased to 70L/min when anesthetic induction begins. As soon as the patient loses consciousness, a facemask connected to a standard anaesthetic machine will be applied on top of the Optiflow Switch nasal cannula . Bag-mask ventilation (BMV) will then commence while waiting for muscle relaxation. After 90 seconds of BMV, patient will then be intubated while high flow oxygen at 70L/min continues to be delivered through the nasal cannula. The Optiflow device will then be removed once patient is intubated. Non-compliance to the intervention will be recorded as "failure rate - need to abandon the allocated device", which is one of the secondary outcomes.


Locations(1)

VIC, Australia

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ACTRN12624000867594