Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000985189
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
10/07/2019
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxyfriend: A novel silicone device which aims to improve preoxgenation in healthy
individuals.
Scientific title
Oxyfriend: A novel silicone device which aims to improve preoxgenation in healthy
individuals.
Secondary ID [1] 298545 0
Nil Known
Universal Trial Number (UTN)
U1111-1235-7896
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre operateive oxygenation 313397 0
Condition category
Condition code
Anaesthesiology 311827 311827 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Oxyfriend is a device consist of a small moulded silicone bridge which is used to secure the nasal cannula under the anaesthetic mask and improve oxygenation. The interventions will consist of comparing oxygenation of awake subjects utilising 100% oxygen and comparing the effectiveness of oxygenation between the anaestehtic mask arm and the anaesthetic mask plus Oxyfriend arm. The constant in this experiment will be that the investigator will be conducting both arms of the experiment so that preoxygenation technique is not altered. The data will be collected over 6 separate interventions which will be held back to back with a rest in between to allow normalisation of oxygenation of the subjects, 2 minute duration. The three interventions in this arm will be :
1. Anaesthetic mask
2. Anaesthetic mask and nasal cannula
3. Anaesthetic mask nasal cannula and Oxyfriend
The data will be collected, which is the end title oxygen after two vital capacity breaths, this will take 1 minute. The estimated overall time of data collection will be around 10 minutes. We will also be conducting a leak test which will conducted after the oxygenation portion and this will consist of all three arms:
1. Anaesthetic mask
2. Anaesthetic mask and nasal prong
3. Anaesthetic, nasal prong and the oxyfriend
The nasal prongs blocked at the oxygen connector end so that no flow occurs through the prongs during the test. The anaesthetic machine will be turned on and the circuit set to the ventilator setting with 4cm water PEEP and 2cm water pressure support. The anaesthetic mask is placed on the participant by the researcher to obtain the optimum seal possible. At the end of 1 minute of normal inspiration tidal volume will be measured and this will allow us to extrapolate the amount leakage which will occur in each arm. The investigator, an intern, will be administering the intervention and will be observed by a specialist anaesthetist and they will make sure all equipment is used appropriately.
Intervention code [1] 314815 0
Treatment: Devices
Comparator / control treatment
The control will be measuring oxygenation utilising a traditional anaesthetic mask which is attached to the anaesthetic circuit.
Control group
Active

Outcomes
Primary outcome [1] 320501 0
End tidal oxygen concentration measured via an anaesthetic machine after utilisation of oxyfriend in conjunction of standard anaesthetic mask and nasal casnnula with 15L/min of oxygen
Timepoint [1] 320501 0
100% oxygen will be administered and the participant will be requested to take 2 vital capacity breaths. At the end of the capacity breaths end title oxygen will be measured.
Secondary outcome [1] 371825 0
The level of leak measured by anaesthetic circuit by prefilling the circuit and measuring the amount of pressure lost over 1 minute. During this time, participants will be instructed to breath normally and the tidal volume, pressure within the circuit and oxygen levels will be closely monitored.
Timepoint [1] 371825 0
At the end of 1 minute of normal inspiration tidal volume will be measured throughout the duration and the pressure within the circuit will be noted at the end of 1 minute

Eligibility
Key inclusion criteria
Voluntary, healthy adult participants from staff and students at Northeast Health Wangaratta.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
age less than 18 years old, presence of relevant co-morbidities such as airway disease
(including but not limited to: asthma and COPD), factors that may cause leak such as beards
and facial abnormalities. Prior exposure to the drugs amiodarone and bleomycin.

Study design
Purpose of the study
Treatment
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired t-tests will be used to analyses the change between different pre-oxygenation times
and leak obtained using the techniques outlined

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14053 0
Northeast Health Wangaratta - Wangaratta
Recruitment postcode(s) [1] 26843 0
3677 - Wangaratta

Funding & Sponsors
Funding source category [1] 303092 0
Hospital
Name [1] 303092 0
Northeast Health Wangaratta
Country [1] 303092 0
Australia
Primary sponsor type
Hospital
Name
Northeast Health Wangaratta
Address
35-47 Green St, Wangaratta VIC 3677
Country
Australia
Secondary sponsor category [1] 303095 0
None
Name [1] 303095 0
Address [1] 303095 0
Country [1] 303095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303636 0
Northeast Health Wangaratta Human Research Ethics Committee
Ethics committee address [1] 303636 0
35-47 Green St, Wangaratta VIC 3677
Ethics committee country [1] 303636 0
Australia
Date submitted for ethics approval [1] 303636 0
23/04/2019
Approval date [1] 303636 0
18/06/2019
Ethics approval number [1] 303636 0

Summary
Brief summary
Preoxygenation is a process which occurs prior to anaesthetising patients prior to surgery. Preoxygenation is a difficult process as it requires placing a mask over a patient’s nose and mouth and creating an air tight seal forcing oxygen from the anaesthetic circuit into the patient’s lungs. The OxyFriend is a novel silicone device which was designed to be utilized with traditional anaesthetic mask. The OxyFriend was designed to improve preoxygenation and my reduce leaking during preoxygenation. The study aims to test whether the OxyFriend will make the process of preoxygenation more effective. A secondary aim to is test whether the OxyFriend will reduce the leakage around the anaesthetic mask.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94346 0
A/Prof Peter Hebbard
Address 94346 0
Northeast Health Wangaratta
35-47 Green St, Wangaratta VIC 3677
Country 94346 0
Australia
Phone 94346 0
+613 5722 5111
Fax 94346 0
Email 94346 0
[email protected]
Contact person for public queries
Name 94347 0
Dr Ahmad Al Helwani
Address 94347 0
Northeast Health Wangaratta
35-47 Green St, Wangaratta VIC 3677
Country 94347 0
Australia
Phone 94347 0
+61 3 5722 5111
Fax 94347 0
Email 94347 0
[email protected]
Contact person for scientific queries
Name 94348 0
Dr Ahmad Al Helwani
Address 94348 0
Northeast Health Wangaratta
35-47 Green St, Wangaratta VIC 3677
Country 94348 0
Australia
Phone 94348 0
+61 3 5722 5111
Fax 94348 0
Email 94348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


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.