Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000337370
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
3/03/2017
Date last updated
14/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Addition of nasal cannula can either impair or enhance preoxygenation with a bag valve mask: a randomised crossover trial comparing oxygen flow rates
Scientific title
Comparison of end-tidal oxygen at 3-minutes using a combination nasal cannulae at different flow rates and a bag valve mask in healthy volunteers
Secondary ID [1] 291295 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intubation 302259 0
preoxygenation 302262 0
Condition category
Condition code
Anaesthesiology 301857 301857 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design is five-period crossover study (repeated measures design). Participants will be required to complete five trials of 3-minutes pre-oxygenation with 100% oxygen in using a bag valve mask (BVM) (at 15l/min) and nasal cannula (NC) in all of the following conditions; BVM alone, BVM+NC at 0l/min, BVM+NC at 5l/min, BVM+NC at 10l/min, BVM+NC at 15l/min, At the end of each trial, oxygen will be measured by an expiratory breath into an oxygen analyser. There will be followed by a washout period of 2 minutes after which the ETO2 will be remeasured to ensure it is within 1% of the participants baseline.
Intervention code [1] 297320 0
Treatment: Drugs
Intervention code [2] 297321 0
Treatment: Devices
Comparator / control treatment
The BVM-only condition is the comparator.
Control group
Active

Outcomes
Primary outcome [1] 301284 0
End-tidal oxygen, assessed with a paramagnetic oxygen analyser from a standard anaesthetic machine. The same analyser will be used for all trials.
Timepoint [1] 301284 0
after 3-minutes of preoxygenation
Secondary outcome [1] 332197 0
Comfort of breathing as measured by visual analog scale
Timepoint [1] 332197 0
after 3-minutes of preoxygenation

Eligibility
Key inclusion criteria
No regular cardiovascular or respiratory medication, no history of chronic respiratory disease.
Attendees at the Greater Sydney Area HEMS governance day,
Minimum age
16 Years
Maximum age
70 Years
Sex
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)
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 'R'.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The sequence by which the trials are to conducted will by a 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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
1/06/2016
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
40
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15468 0
2200 - Bankstown Aerodrome

Funding & Sponsors
Funding source category [1] 295763 0
Government body
Name [1] 295763 0
Ambulance NSW
Country [1] 295763 0
Australia
Primary sponsor type
Government body
Name
Ambulance Service NSW
Address
Aeromedical and retreival services
Drover Road
Bankstown Airport
NSW 2200
Country
Australia
Secondary sponsor category [1] 294609 0
None
Name [1] 294609 0
nil
Address [1] 294609 0
nil
Country [1] 294609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297061 0
Sydney Local Health District
Ethics committee address [1] 297061 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 297061 0
Australia
Date submitted for ethics approval [1] 297061 0
09/12/2015
Approval date [1] 297061 0
11/02/2016
Ethics approval number [1] 297061 0
HREC/15/RPAH/587

Summary
Brief summary
Objectives
A critical safety component of emergency anaesthesia is
the avoidance of hypoxaemia during the apnoeic phase of a rapid sequence intubation. Preoxygenation with a bag valve mask (BVM) or anaesthetic circuit may be improved with supplemental oxygen by nasal cannulae (NC) if there is a mask leak. In addition, NC are recommended for apnoeic oxygenation after induction and may be placed prior to preoxygenation
.
However, the optimum NC flow rate for preoxygenation or whether presence of NC itself creates a mask leak remains unclear.
Methods
We performed a randomized crossover study on healthy volunteers comparing BVM alone and BVM with NC flow rates of 0 (NC-0), 5 (NC-5), 10 (NC-10) and 15 (NC-15) litres per minute
.
Our primary outcome was end tidal oxygen (ETO2) after 3-minutes preoxygenation.
Trial website
Trial related presentations / publications
Mcquade D, Miller MR, Hayes-Bradley C. Addition of Nasal Cannula Can Either Impair or Enhance Preoxygenation With a Bag Valve Mask: A Randomized Crossover Design Study Comparing Oxygen Flow Rates. Anesthesia & Analgesia 2017; Publish Ahead of Print
Public notes

Contacts
Principal investigator
Name 72842 0
Dr David McQuade
Address 72842 0
Department of Emergency Medicine
Wellington Hospital
Riddiford St, Newtown,
Wellington 6021
Country 72842 0
New Zealand
Phone 72842 0
+64 4385 5999
Fax 72842 0
Email 72842 0
[email protected]
Contact person for public queries
Name 72843 0
Matthew Miller
Address 72843 0
Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Country 72843 0
Canada
Phone 72843 0
+1 4162784580
Fax 72843 0
Email 72843 0
[email protected]
Contact person for scientific queries
Name 72844 0
Matthew Miller
Address 72844 0
Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Country 72844 0
Canada
Phone 72844 0
+1 4162784580
Fax 72844 0
Email 72844 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
SourceTitleYear of PublicationDOI
EmbaseAddition of nasal cannula can either impair or enhance preoxygenation with a bag valve mask: A randomized crossover design study comparing oxygen flow rates.2018https://dx.doi.org/10.1213/ANE.0000000000002341
N.B. These documents automatically identified may not have been verified by the study sponsor.