Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001087549
Ethics application status
Approved
Date submitted
10/09/2015
Date registered
16/10/2015
Date last updated
16/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of supplemental nasal prong oxygen during standard pre-oxygenation techniques in healthy volunteers.
Scientific title
Effect of supplementation of standard emergency preoxygenation techniques with nasal prong oxygen on end tidal oxygen in healthy adults.
Secondary ID [1] 287448 0
Nil
Universal Trial Number (UTN)
U1111-1174-2479
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preoxygenation 296168 0
Condition category
Condition code
Anaesthesiology 296449 296449 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised crossover trial

The five preoxygenation techniques include:
1. “Non rebreather” mask
Non-rebreather mask involves wearing a mask over the mouth and nose, held by an elastic round the back of the head. The mask is attached to a reservoir bag which re-fills with oxygen from a tank as the participant inhale. The oxygen flow rate is 15L/minute.
2. “Non rebreather” mask at maximum flow rate.
The flow rate is unmeasured but approximately 30-40L/min.
3. ”Non rebreather” mask at 15l/min + Nasal Oxygen 10l/min
Nasal Oxygen involves wearing nasal prongs in the nose with oxygen delivered at 10L/minute
4. Bag valve / mask
Bag valve /mask involves wearing a tightly held mask over the mouth and nose. The mask is attached a oxygen source at 15L/min.
5. Bag valve / mask 15l/min+ Nasal Oxygen 10l/min

100% Oxygen was used for all run at the flow rates listed above

Each participant will do each of the above techniques (1-5) in a random order.
Each technique will consist of a run with 16 deep breaths over 2 minutes, followed by a washout period of 3 minutes then a run with 3 minutes tidal breathing for each technique.

After each technique (that is, both 16 deep breaths and 3 minutes tidal breathing runs) there will be a 3 minute wash out period before the next technique

End tidal oxygen fraction will be measure by capnography on the anaesthesia machine


Results will be logged

Intervention code [1] 292820 0
Treatment: Other
Intervention code [2] 292821 0
Treatment: Devices
Comparator / control treatment
Bag valve / mask preoxygenation (Technique 4)
This is a commonly used technique in emergency pre oxygenation
Control group
Active

Outcomes
Primary outcome [1] 296065 0
End tidal O2 measure by capnography
Timepoint [1] 296065 0
Immediately post pre oxygenation
Secondary outcome [1] 317419 0
Tolerance - assessed with a visual analogue scale by participant
Timepoint [1] 317419 0
Immediately post pre-oxygenation

Eligibility
Key inclusion criteria
1. Fit and healthy
2. Age > 18
3. English speaking
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant cardiac or respiratory disease
2. No consent
3. Pregnancy

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)
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited by a junior member of staff
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to a treatment sequence based on a Latin square design

The treatment sequence will be revealed immediately before the procedure in a sealed envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 20 ensures a balanced design allowing for 4 participants per sequence (five sequences) and is sufficient to determine a 15% difference in pairwise treatment comparisons, allowing for up to 10 pairwise comparisons, with >80% power, overall alpha 0.05, based on end tidal O2 fraction mean 58.0% sd 7.3% in non rebreather mask at 10L/min after 3 minutes of preoxygenation (Robinson A, Ercole A. Evaluation of the self-inflating bag-valve-mask and non-rebreather mask as preoxygenation devices in volunteers. BMJ Open 2012;2:e001785. doi:10.1136/bmjopen-2012-001785).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/08/2015
Date of last participant enrolment
Anticipated
31/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4332 0
King Edward Memorial Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 292019 0
Hospital
Name [1] 292019 0
King Edward Memorial Hospital
Country [1] 292019 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
King Edward Memorial Hospital
374 Bagot rd
Subiaco
Western Australia
6008
Country
Australia
Secondary sponsor category [1] 290689 0
None
Name [1] 290689 0
Address [1] 290689 0
Country [1] 290689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293507 0
King Edward Memorial Hospital
Ethics committee address [1] 293507 0
King Edward Memorial Hospital for Women (KEMH) Ethics & Research Governance
Address: GPO Box D184
Perth
WA
6840
Ethics committee country [1] 293507 0
Australia
Date submitted for ethics approval [1] 293507 0
Approval date [1] 293507 0
04/07/2014
Ethics approval number [1] 293507 0

Summary
Brief summary
The 2 most common breathing methods of pre-oxygenation involve 8 deep breaths over 60 seconds or 3 minutes of tidal volume breathing (normal breathing) using high flow oxygen. In the operating theatre this involves an anaesthesia machine that can deliver 100% oxygen at 15L/minute. In the emergency department, an anaesthesia machine is not present so a simple non rebreather mask or a bag valve /mask kit is used. Typically both of these devices can only deliver 60 -70% oxygen, so pre-oxygenation is often inadequate in these settings.

In the recent KEMH anaesthesia preoxygenation trial we found that nasal prongs improved preoxygenation effectiveness when used with the anaesthesia machine. We are examining if nasal prong oxygen also improves preoxygenation when non rebreather mask and bag valve / masks are used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60230 0
Dr Twain Russell
Address 60230 0
King Edward Memorial Hospital 374 Bagot rd Subiaco WA 6008
Country 60230 0
Australia
Phone 60230 0
+6189340 2222
Fax 60230 0
Email 60230 0
[email protected]
Contact person for public queries
Name 60231 0
Dr Twain Russell
Address 60231 0
King Edward Memorial Hospital 374 Bagot rd Subiaco WA 6008
Country 60231 0
Australia
Phone 60231 0
+6189340 2222
Fax 60231 0
Email 60231 0
[email protected]
Contact person for scientific queries
Name 60232 0
Dr Twain Russell
Address 60232 0
King Edward Memorial Hospital 374 Bagot rd Subiaco WA 6008
Country 60232 0
Australia
Phone 60232 0
+6189340 2222
Fax 60232 0
Email 60232 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.