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Trial registered on ANZCTR


Registration number
ACTRN12624000867594p
Ethics application status
Not yet submitted
Date submitted
13/06/2024
Date registered
16/07/2024
Date last updated
16/07/2024
Date data sharing statement initially provided
16/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effectiveness of using Optiflow Switch vs standard facemask during anaesthesia induction: a randomized controlled trial
Scientific title
Comparing the effectiveness of using Optiflow Switch vs standard facemask during anaesthesia induction in adults: a randomized controlled trial
Secondary ID [1] 312163 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology 333880 0
Condition category
Condition code
Anaesthesiology 330557 330557 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 50L.min will be provided during pre-oxygenation before induction. 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.
Intervention code [1] 328651 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will receive usual care. In standard care, participants will receive pre-oxygenation through a standard facemask, which is connected to an anaesthetic machine set on manual ventilation mode. Bag-mask ventilation will commence as soon as the patient loses consciousness. BMV will continue while waiting for muscle relaxation. After 90 seconds of BMV, anaesthetist will then remove the facemask and commence intubation.
Control group
Active

Outcomes
Primary outcome [1] 338359 0
To compare the partial pressure of oxygen (PaO2) immediately post-intubation in patients having oxygen delivery through Optiflow Switch vs standard facemask during anaesthesia induction.
Timepoint [1] 338359 0
After successful intubation and before mechanical ventilation is commenced.
Secondary outcome [1] 435635 0
To compare the partial pressure of oxygen (PaO2) after 3-minute pre-oxygenation and immediately pre intubation between the two oxygen delivery techniques.
Timepoint [1] 435635 0
After three minutes of pre-oxygenation and Immediately before intubation.
Secondary outcome [2] 436195 0
To compare the partial pressure of carbon dioxide (PaCO2) after 3-minute pre-oxygenation; immediately pre-intubation and immediately post-intubation between the two oxygen delivery techniques.
Timepoint [2] 436195 0
After three minutes of pre-oxygenation, immediately before intubation and immediately after intubation.
Secondary outcome [3] 436197 0
To compare the saturation of peripheral oxygen (SpO2) after 3-minute pre-oxygenation; immediately pre-intubation and immediately post-intubation between the two oxygen delivery techniques.
Timepoint [3] 436197 0
After three minutes of pre-oxygenation, immediately before intubation and immediately after intubation.
Secondary outcome [4] 436198 0
To compare the number of hypoxic episodes (oxygen saturation below 90%) during anaesthetic induction (from pre-oxygenation till successful intubation) between the two oxygen delivery techniques.
Timepoint [4] 436198 0
During anaesthetic induction (from pre-oxygenation till successful intubation).
Secondary outcome [5] 436199 0
To compare failure rate (need to abandon the allocated device or abandon the protocol) between the two oxygen delivery techniques.
Timepoint [5] 436199 0
During anaesthetic induction (from pre-oxygenation till successful intubation).
Secondary outcome [6] 436200 0
Ability to obtain a seal to bag-mask ventilate (BMV) over the Optiflow Switch.
Timepoint [6] 436200 0
During anaesthetic induction (from pre-oxygenation till successful intubation).
Secondary outcome [7] 436201 0
To compare airway adjuncts used between the two oxygen delivery techniques.
Timepoint [7] 436201 0
During anaesthetic induction (from pre-oxygenation till successful intubation).
Secondary outcome [8] 436203 0
To compare the train of four (TOF) counts and ratios at the time of first intubation attempt between the two oxygen delivery techniques.
Timepoint [8] 436203 0
At the time of first intubation attempt.
Secondary outcome [9] 436204 0
To compare time taken for successful intubation between the two oxygen delivery techniques.
Timepoint [9] 436204 0
From the time of insertion of laryngoscope till successful intubation.
Secondary outcome [10] 436205 0
To compare the number of intubation attempts between the two oxygen delivery techniques.
Timepoint [10] 436205 0
During intubation attempts
Secondary outcome [11] 436206 0
To compare all other complications, such as hypoxia, arrhythmia, myocardial ischaemia, cardiac or respiratory arrest, between the two oxygen delivery techniques.
Timepoint [11] 436206 0
During anaesthetic induction (from pre-oxygenation till successful intubation).
Secondary outcome [12] 436207 0
To compare patient's tolerance to the device between the two oxygen delivery techniques.
Timepoint [12] 436207 0
During the pre-oxygenation phase.
Secondary outcome [13] 436209 0
Anaesthetists’ rating on the ease of bag-mask ventilation over the Optiflow Switch, overall satisfaction score and any other comments.
Timepoint [13] 436209 0
After successful intubation.
Secondary outcome [14] 436224 0
To compare the success rate of bag-mask ventilation between the two oxygen delivery techniques.
Timepoint [14] 436224 0
During bag-mask ventilation.
Secondary outcome [15] 437058 0
To compare intubation success rate between the two oxygen delivery techniques
Timepoint [15] 437058 0
During intubation attempts
Secondary outcome [16] 437059 0
To compare intubation technique used between the two oxygen delivery techniques
Timepoint [16] 437059 0
During intubation attempts
Secondary outcome [17] 437060 0
To compare the need to revert back to bag-mask ventilation during intubation between the two oxygen delivery techniques
Timepoint [17] 437060 0
During intubation attempts

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) in blocks of ten.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316527 0
Hospital
Name [1] 316527 0
The Royal Melbourne Hospital
Country [1] 316527 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 318798 0
None
Name [1] 318798 0
Address [1] 318798 0
Country [1] 318798 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315321 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315321 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 315321 0
Australia
Date submitted for ethics approval [1] 315321 0
22/07/2024
Approval date [1] 315321 0
Ethics approval number [1] 315321 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134330 0
A/Prof Irene Ng
Address 134330 0
300 Grattan Street, The Royal Melbourne Hospital, 3N Department of Anaesthesia and Pain, Parkville VIC 3050
Country 134330 0
Australia
Phone 134330 0
+613 93427540
Fax 134330 0
Email 134330 0
[email protected]
Contact person for public queries
Name 134331 0
Shan Hung
Address 134331 0
300 Grattan Street, The Royal Melbourne Hospital, 3N Department of Anaesthesia and Pain, Parkville VIC 3050
Country 134331 0
Australia
Phone 134331 0
+613 93428107
Fax 134331 0
Email 134331 0
[email protected]
Contact person for scientific queries
Name 134332 0
Irene Ng
Address 134332 0
300 Grattan Street, The Royal Melbourne Hospital, 3N Department of Anaesthesia and Pain, Parkville VIC 3050
Country 134332 0
Australia
Phone 134332 0
+613 93427540
Fax 134332 0
Email 134332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.