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Trial registered on ANZCTR


Registration number
ACTRN12617000339358
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
3/03/2017
Date last updated
1/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
End-tidal oxygen achieved with preoxygenation via non-rebreather mask at different flow rates in healthy volunteers
Scientific title
Efficacy of preoxygenation via non-rebreather mask, comparing standard oxygen flow at 15lpm to maximally opened flow meter in healthy participants
Secondary ID [1] 286452 0
Nil
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation 294627 0
preoxygenation 302257 0
Condition category
Condition code
Anaesthesiology 294927 294927 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design is two-period crossover study (repeated measures design) . Participants will complete two trials of 3-minutes pre-oxygenation via non-rebreather mask (NRM)., One trial will have an oxygen flow rate of 15lpm, The other will have the flow-meter valve turned wide open. The end-tidal oxygen (ETO2) will be measured at the end of each trial. The first trial will be followed by a washout period of 2 minutes. Allocation to the first trial (15lpm or fully open valve) will be randomised.
Intervention code [1] 297316 0
Treatment: Drugs
Intervention code [2] 297317 0
Treatment: Devices
Comparator / control treatment
The NRM at 15l/min is the control.
Control group
Active

Outcomes
Primary outcome [1] 301281 0
End-tidal oxygen after 3-minutes of preoxygenation will be assessed with a paramagnetic oxygen analyser from a standard anaesthetic machine. The same analyser will be used for all trials.
Timepoint [1] 301281 0
at 3 minutes
Secondary outcome [1] 332193 0
Nil
Timepoint [1] 332193 0
Nil

Eligibility
Key inclusion criteria
No regular cardiovascular or respiratory medication, no history of chronic respiratory disease.

Attendees at NSW Ambulance Aeromedical service governance days. We are not allowed to recruit outside of this site.
Minimum age
16 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, lung disease, known or suspected coronary or cerebrovascular disease, treatment for asthma or
COPD, previous exposure to bleomycin, participants with beards, dentures or facial abnormalities affecting mask
seal.

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 order of trials will be randomised. This randomisation will be performed using a random sequence generated using the statistical software “R”. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence generation by statistical software package.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
balanced Latin-Squares design. This allows the sequence of trials to be randomised, but balanced so that, if one participant was to conduct the trials in a particular order, another participant will perform their trials in the reverse of that order.
Phase
Phase 2
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis
Analysis will be by paired hypothesis test depending on parametric or non-parametric distribution of the data

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295762 0
Government body
Name [1] 295762 0
Ambulance NSW
Address [1] 295762 0
Aero medical and retrieval services
Drover Rd
Bankstown
Nsw 2200
Country [1] 295762 0
Australia
Primary sponsor type
Government body
Name
NSW Ambulance
Address
Aeromedical Services
Drover Road
Bankstown Airport
2200
NSW
Country
Australia
Secondary sponsor category [1] 294608 0
None
Name [1] 294608 0
nil
Address [1] 294608 0
nil
Country [1] 294608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297059 0
Sydney Local Health District
Ethics committee address [1] 297059 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 297059 0
Australia
Date submitted for ethics approval [1] 297059 0
09/12/2015
Approval date [1] 297059 0
11/02/2016
Ethics approval number [1] 297059 0
HREC/15/RPAH/587

Summary
Brief summary
Preoxygenation is critical to safe emergency airway management. Outside of the operating theatre and in prehospital environments, ‘Over flow’ from a standard wall/cylinder outlet has been proposed to greatly enhance preoxygenation via a Non-rebreather mask (NRB). Methods We performed a randomised crossover trial using two preoxygenation conditions; a NRB at 15lpm and the other a NRB with the 15lpm flowmeter with the dial turned all
the way open (over-flow). End-tidal oxygen (ETO2) as a measure of preoxygenation/denitrogenating efficacy, was measured by single exhaled vital capacity breath.
Trial website
Trial related presentations / publications
Hayes-Bradley C, Mcquade D, Miller M. Preoxygenation via a non-rebreather mask comparing a standard oxygen flowmeter rate of 15?Lpm to maximally open. Emerg Med Australas 2017; 59: 165 . epub ahead of print. http://doi.wiley.com/10.1111/1742-6723.12784


Public notes

Contacts
Principal investigator
Name 56182 0
Dr David McQuade
Address 56182 0
Department of Emergency Medicine
Wellington Hospital
Riddiford St, Newtown,
Wellington 6021,
Country 56182 0
New Zealand
Phone 56182 0
+64 4385 5999
Fax 56182 0
Email 56182 0
davidmcq@gmail.com
Contact person for public queries
Name 56183 0
Dr Matthew Miller
Address 56183 0
Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada
Country 56183 0
Canada
Phone 56183 0
+1 4162784580
Fax 56183 0
Email 56183 0
mattdotmiller@gmail.com
Contact person for scientific queries
Name 56184 0
Dr Matthew Miller
Address 56184 0
Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada
Country 56184 0
Canada
Phone 56184 0
+1 416 278 4580
Fax 56184 0
Email 56184 0
mattdotmiller@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary