Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001040257
Ethics application status
Approved
Date submitted
15/06/2018
Date registered
21/06/2018
Date last updated
21/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of a silicon device to improve delivery of oxygen to patients before surgery.
Scientific title
Can the use of a silicon adjunct decrease leak and improve pre-oxygenation in healthy individuals?
Secondary ID [1] 295213 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre oxygenation in surgical patients 308360 0
Condition category
Condition code
Anaesthesiology 307354 307354 0 0
Anaesthetics
Surgery 307389 307389 0 0
Other surgery
Emergency medicine 307390 307390 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For all of the below the OxyFriend is a U shaped silicon device which sits over the bridge of the nose and extends down either side of the mouth. It has an indentation on either side to allow passage of nasal cannulae.

Pre-oxygenation testing
The alternatives to be tested are
1. End tidal oxygen using anaesthetic mask and circuit alone 2 vital capacity breaths, 100% oxygen circuit flow set to maximum (15 litres/min)
2. End tidal oxygen using nasal prongs at 15 litres per minute and anaesthetic mask, 2 vital capacity breaths 100% oxygen circuit flow set to maximum (15 litres/min)
3. End tidal oxygen using nasal prongs at 15 litres per minute with OxyFriend and anaesthetic mask, 2 vital capacity breaths, 100% oxygen circuit flow set to maximum (15 litres/min)
The experiment will be conducted in a random order between subjects. 4 groups of 6 envelopes, each envelope in the group has a different one of the 6 possible orders of tests. 4 envelopes from one group discarded to make 20 envelopes which will be randomly selected for each test.
Subjects will be tested lying down with the anaesthetic face mask held on by the same researcher for all subjects.
Flow for nasal prongs via oxygen outlet will be set to 15 litres per minute measured using the flow meter of the anaesthetic machine.
Prior to commencement of the experiment the participants will be familiarised with the mask, OxyFriend and nasal prongs including experiencing breathing on the anaesthetic circuit with and without the nasal prongs flowing at 15 litres/min. A technique of expiring the last breath through the filter attached to the oxygen analyser will be practiced as will taking 2 vital capacity breaths commencing with a full expiration and application of the anaesthetic mask.
To commence the experiment the 1st selected configuration is placed on the subject (nasal prongs, OxyFriend with nasal prongs or neither), the nasal prongs are not connected to the oxygen at 15 litres/min until the start of the preoxygenation test. The subject breathes through a filter connected to the side stream oxygen analyser until end expired oxygen is less than or equal to 18% (facilitated by deep expirations and breath holding in expiration), this will indicate a baseline oxygen state. The anaesthetic circuit and bag will be flushed with 100% oxygen prior to the commencement of each test.
The subject will breath out deeply to commence the test, at the peak of expiration the nasal prongs will be connected to the 15 litres/min oxygen flow of required, and the anaesthetic mask applied to the face. For the 2-vital capacity experiments the subjects will inhale fully, exhale fully and then inhale fully again (2 vital capacity breaths). This will take approximately 10 seconds. At full inspiration the anaesthetic face mask will be removed and the nasal prongs disconnected from the oxygen source. The subject will place the filter connected to the oxygen analyser in their mouth and breath out to the end of a normal breath (functional residual capacity). The end expired oxygen reading from the side stream oxygen analyser will be recorded. The participant will continue breathing via the filter until the expired oxygen returns to baseline (less than or equal to 18%).

All participants will undergo all six tests- they will be required to have end tidal O2 return to 18 before before re-testing or pre-oxygenation.

The participant will then be prepared for the next test as determined by the randomisation until 3 tests are completed.
Expected duration 15 minutes for all three tests

Mask leak testing
Equipment required
1. Disposable
Anaesthetic face mask (sized according to the participant’s face), elbow, nasal prongs and 1 breathing system filter, Oxyfriend device (All reused from preoxygenation test).

2. Non disposable
Anaesthetic machine (gas delivery system, leak tested hoses, flow sensors) with instantaneous side flow oxygen analyser and spirometry capacity to display inspired and expired minute ventilation separately. Timer

The alternatives to be tested are

1. Mask leak using anaesthetic facemask alone, 50% oxygen flow
2. Mask leak using anaesthetic facemask and nasal prongs, 50% oxygen flow
3. Mask leak using anaesthetic facemask, nasal prongs and OxyFriend, 50% oxygen flow

Prior to the commencement the participants will be familiarised with the mask, OxyFriend and nasal prongs including experiencing breathing on the anaesthetic circuit with a low level of positive end expiratory pressure (PEEP) with and without the nasal prongs and the OxyFriend.

Subjects will be tested lying down with the anaesthetic face mask held on by the same researcher for all subjects.

To commence the experiment the 1st selected configuration is placed on the subject (nasal prongs, OxyFriend with nasal prongs or neither), 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. The subject will commence breaths of normal tidal volume and rate (normal breathing). The oxygen/air mix added to the circuit will be adjusted to keep the ventilator bag about 2/3 full at the end of expiration. This is to prevent increased circuit pressure by forcing open the spill valve. The oxygen flush may be used to fill the circuit if needed, at least 50% oxygen will be added to the circuit from the anaesthetic machine to ensure that the gas mix that the patient is breathing is not hypoxic (the oxygen concentration in the circuit will be continuously monitored through the oxygen side stream analyser). After 30 seconds of normal breathing the timer will be started and the test continued for 1 minute. The inspired and expired minute volume will be recorded at the end of the minute. The mask will be removed and the next configuration of prongs, OxyFriend or neither placed on the subject and the test will be repeated until all three tests are complete.

Expected duration 10 minutes for all three tests
Intervention code [1] 301551 0
Treatment: Devices
Comparator / control treatment
Reference group- mask alone

Comparator 1- mask and nasal prongs and Oxyfriend
Comparator 2- mask and nasal prongs
Control group
Active

Outcomes
Primary outcome [1] 306321 0
Change in end tidal O2 levels between the three groups being investigated as assessed by the anaesthetics machine gas analyser.
Timepoint [1] 306321 0
1. After 2 vital capacity breaths for all three tests.
Secondary outcome [1] 348263 0
Change in air leak after one minute of breathing between intervention groups as assessed by the spirometry flow function on the anaesthetics machine.
Timepoint [1] 348263 0
After one minute after each of the tree tests

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
Exclusion: age <18years 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)
The experiment will be conducted in a random order between subjects. 4 groups of 6 envelopes, each envelope in the group has a different one of the 6 possible orders of tests. 4 envelopes from one group discarded to make 20 envelopes which will be randomly selected for each test. Envelopes will be opaque, sealed and numbered.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation for order of testing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
We aim to recruit 20 participants which should adequately power the experiment to identify statistically significant differences. Power analysis based on paired t test of primary outcome (mean difference in end tidal oxygen 10%, standard deviation 10, alpha 0.025, beta 0.2) sample size 10.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/06/2018
Date of last participant enrolment
Anticipated
6/07/2018
Actual
Date of last data collection
Anticipated
6/07/2018
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11150 0
Northeast Health Wangaratta - Wangaratta
Recruitment postcode(s) [1] 22975 0
3677 - Wangaratta

Funding & Sponsors
Funding source category [1] 299801 0
Self funded/Unfunded
Name [1] 299801 0
A/ Prof Peter Hebbard
Country [1] 299801 0
Australia
Funding source category [2] 299802 0
Hospital
Name [2] 299802 0
Northeast Health Wangaratta
Country [2] 299802 0
Australia
Primary sponsor type
Individual
Name
A/ Prof Peter Hebbard
Address
Northeast Health Wangaratta
35-47 Green St, Wangaratta, Vic, 3677
Country
Australia
Secondary sponsor category [1] 299150 0
Hospital
Name [1] 299150 0
Northeast Health Wangaratta
Address [1] 299150 0
35-47 Green St, Wangaratta, Vic, 3677
Country [1] 299150 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300684 0
Northeast Health Wangaratta Human Research Ethical Committee Certification of Approval
Ethics committee address [1] 300684 0
Ethics committee country [1] 300684 0
Australia
Date submitted for ethics approval [1] 300684 0
01/04/2018
Approval date [1] 300684 0
10/04/2018
Ethics approval number [1] 300684 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84466 0
A/Prof Peter Hebbard
Address 84466 0
Northeast Health Wangaratta
35-47 Green St, Wangaratta
Victoria, 3677
Country 84466 0
Australia
Phone 84466 0
+61357225233
Fax 84466 0
Email 84466 0
[email protected]
Contact person for public queries
Name 84467 0
Adam Levin
Address 84467 0
Northeast Health Wangaratta
35-47 Green St, Wangaratta
Victoria, 3677
Country 84467 0
Australia
Phone 84467 0
+61357225233
Fax 84467 0
Email 84467 0
[email protected]
Contact person for scientific queries
Name 84468 0
Peter Hebbard
Address 84468 0
Northeast Health Wangaratta
35-47 Green St, Wangaratta
Victoria, 3677
Country 84468 0
Australia
Phone 84468 0
+61357225233
Fax 84468 0
Email 84468 0
[email protected]

No information has been provided regarding IPD availability


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.