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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000867594
Enrollment
50
Registered
2024-07-16
Start date
2025-04-08
Completion date
2026-04-07
Last updated
2026-07-13

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

Conditions

None listed

Brief 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.

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 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,

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.

Sponsors

Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient inclusion criteria: • Adult patients aged great than or equal to 18 years • American Society of Anaesthesiologists physical status classification (ASA) 1-3 • Able to give informed consent • Having surgical operation, requiring general anaesthesia for asleep oro-tracheal intubation • Require arterial line insertion pre-operatively

Exclusion criteria

Exclusion criteria: • Non-English speaking • Risk of aspiration • Known or anticipated difficult airway • Patients require awake fibre-optic intubation, gas induction or rapid sequence induction • Known allergy to propofol or rocuronium • Known basal skull fracture • Active nasal bleed

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026