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Trial registered on ANZCTR


Registration number
ACTRN12619000652178p
Ethics application status
Not yet submitted
Date submitted
16/04/2019
Date registered
1/05/2019
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate the utility of Optiflow for Pre oxygenation.
Scientific title
A study to investigate the utility of Optiflow for Pre oxygenation prior to anaesthesia.
Secondary ID [1] 297994 0
None
Universal Trial Number (UTN)
U1111-1231-9048
Trial acronym
Linked study record
This study is being conducted with the same participants as another study (ACTRN12619000613101). The studies have distinct hypotheses and endpoints and will be conducted in series, with this study to be conducted immediately prior to induction of anaesthesia whereas the other study will be conducted after the induction of anaesthesia.

Health condition
Health condition(s) or problem(s) studied:
Desaturation/oxygenation during anaesthesia 312419 0
airway management 312420 0
Condition category
Condition code
Anaesthesiology 310980 310980 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive four minutes of 50l/min of Nasal High Flow delivered from a prototype flow source, a humidifier, a water chamber, a breathing tube, and a non sealing nasal interface. The treatment will be administered in an operating room under the direction of an anaesthetist immediately prior to induction of anaesthesia

The case report form will record the duration of the intervention, the flows delivered and any variations to the protocol.

This study is being conducted with the same participants as another study (ACTRN12619000613101). The studies have distinct hypotheses and endpoints and will be conducted in series, with this study to be conducted immediately prior to induction of anaesthesia whereas the other study will be conducted after the induction of anaesthesia.
Intervention code [1] 314220 0
Treatment: Devices
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319779 0
PaO2 at 3 minutes after the start of pre-oxygenation
An arterial blood gas sample will be taken from an arterial line and a standard blood gas analyser will be used to determine the PaO2.
Timepoint [1] 319779 0
3 minutes after the start of pre-oxygenation
Secondary outcome [1] 369526 0
PaO2 at t=0,1,2,3,4 minutes as measured by arterial blood gas drawn from an arterial line and analysed in a standard blood gas analyser
Timepoint [1] 369526 0
t=1,2,3,0,4 minutes of preoxygenation
Secondary outcome [2] 369529 0
Oxygen reserve index at t = 0,1,2,3,4 minutes as measured using an oxygen reserve index device (Masimo).
Timepoint [2] 369529 0
t = 0,1,2,3,4 minutes of preoxygenation
Secondary outcome [3] 369530 0
PaO2 at t=0,1,2,3,4 minutes as measured by transcutaneous monitoring (radiometer TCM-5)
Timepoint [3] 369530 0
t=0,1,2,3,4 minutes of preoxygenation
Secondary outcome [4] 369531 0
SpO2 as measured continuously by a standard pulse oximeter
Timepoint [4] 369531 0
t=0,1,2,3,4 minutes

Eligibility
Key inclusion criteria
• 16 years and over and less than 80 years in age
• Capable of informed consent
• Undergoing laryngotrachael surgery under general anaesthetic expected to last at least 15 minutes
Minimum age
16 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI > 35 kg/m2.
• negative Allen’s test for arterial competency (ulnar).
• unstable angina or a recent (<6 month old) myocardial infarction
• Severe hypertension (diastolic blood pressure >120mmHg)
• Uncontrolled cardiac arrhythmias
• Uncontrolled heart failure
• Active myocarditis, endocarditis or pericarditis
• Known cyanotic congenital heart disease
• significantly decreased myocardial function ( ejection fraction < 50%)
• significant conduction abnormalities ( 2nd and 3rd degree AV block, left bundle branch block, bifascicular block) and abnormal cardiac rhythm, except for isolated, asymptomatic
• premature atrial and ventricular contractions.
• Current pulmonary embolism
• Symptomatic severe aortic stenosis
• Room-air saturation levels <85%
• requiring preoperative oxygen therapy secondary to chronic lung disease
• Pre-existing hypoxemia
• clinically-defined severe concomitant lower airway pulmonary disease
• quadriplegia or paraplegia
• Known contraindication to Optiflow™ device
• Patients in whom CPAP is contraindicated (e.g. pneumothorax, bullous lung disease, craniofacial trauma, airway, foreign body, unstable haemodynamics)
• history or symptoms of increased intracranial pressure or reduced intracranial compliance ( e.g. headaches, nausea and vomiting, visual changes, mental changes) .
• skull base defects.
• known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks ( TIAs) .
• Patients in whom high FiO2 is contraindicated (e.g. patients being treated with Bleomycin)
• Patients who have not been fasted for at least 8 hours.
• severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
• hiatal hernia and full stomach patients.
• Patients undergoing procedures with electrocautery or laser.
• More than 50% (as judged by the anaesthetist) of the nares occluded by the nasal prongs
• Bleeding in nose or oropharynx
• Pre-existing nasal obstruction
• Patients receiving an induction with volatile anaesthetics
• Patients with delicate skin that could be thermally damaged by the transcutaneous monitor

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This study is a supplementary study and the power calculation was performed for the main study.
The data will be reported using standard statistical measures (e.g. mean +/- SD)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21415 0
New Zealand
State/province [1] 21415 0
auckland

Funding & Sponsors
Funding source category [1] 302521 0
Commercial sector/Industry
Name [1] 302521 0
Fisher & Paykel Healthcare
Address [1] 302521 0
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country [1] 302521 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 302431 0
University
Name [1] 302431 0
University of Auckland
Address [1] 302431 0
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 302431 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303172 0
Health and Disability Ethics Commitee - Northern B
Ethics committee address [1] 303172 0
Ministry of Health,
Level 3,Rangitoto Room, Unisys Building,
650 Great South Road, Penrose,
Auckland 1051
Ethics committee country [1] 303172 0
New Zealand
Date submitted for ethics approval [1] 303172 0
07/05/2019
Approval date [1] 303172 0
Ethics approval number [1] 303172 0

Summary
Brief summary
This study aims to answer the question: Is nasal high flow (Optiflow) efficacious for pre-oxygenation? Pre oxygenation is carried out before the induction of anaesthesia to fill the patient's lungs with Oxygen to prolong safe apnoea time. Usual practice is to perform preoxygenation with a bag and mask but this technique has some usability and patient comfort issues. Nasal high flow has been reported to be well tolerated in a number of patient groups and may provide a useful alternative.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92734 0
Prof Alan Merry
Address 92734 0
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 92734 0
New Zealand
Phone 92734 0
+64 9 923 5751
Fax 92734 0
Email 92734 0
a.merry@auckland.ac.nz
Contact person for public queries
Name 92735 0
Mr Matthew Payton
Address 92735 0
Fisher&Paykel Healthcare
15 Maurice Paykel Place
Auckland 2013
Country 92735 0
New Zealand
Phone 92735 0
+64 95740100
Fax 92735 0
Email 92735 0
matthew.payton@fphcare.co.nz
Contact person for scientific queries
Name 92736 0
Mr Matthew Payton
Address 92736 0
Fisher&Paykel Healthcare
15 Maurice Paykel Place
Auckland 2013
Country 92736 0
New Zealand
Phone 92736 0
+64 95740100
Fax 92736 0
Email 92736 0
matthew.payton@fphcare.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data relating to the primary outcome (PaO2) and selected secondary outcomes (those where the data is in a practical form to share such as PaO2, transcutaneous O2/CO2, SpO2)
When will data be available (start and end dates)?
From the completion of the trial for a minimum of 5 years and a maximum of 10 years.
Available to whom?
1. Investigators with applicable consents and ethical approvals.
2. Regulatory bodies
Available for what types of analyses?
Meta analyses or similar reviews
Data verification
How or where can data be obtained?
Following a written request, if the Principal Investigator and Sponsor both approve, then data would be made available as anonymised electronic records.
What supporting documents are/will be available?
Study protocol
Summary results
No Results