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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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

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

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 4332 0
King Edward Memorial Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 292019 0
Name [1] 292019 0
King Edward Memorial Hospital
Address [1] 292019 0
King Edward Memorial Hospital
374 Bagot rd
Western Australia
Country [1] 292019 0
Primary sponsor type
King Edward Memorial Hospital
King Edward Memorial Hospital
374 Bagot rd
Western Australia
Secondary sponsor category [1] 290689 0
Name [1] 290689 0
Address [1] 290689 0
Country [1] 290689 0

Ethics approval
Ethics application status
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
Ethics committee country [1] 293507 0
Date submitted for ethics approval [1] 293507 0
Approval date [1] 293507 0
Ethics approval number [1] 293507 0

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

Principal investigator
Name 60230 0
Dr Twain Russell
Address 60230 0
King Edward Memorial Hospital 374 Bagot rd Subiaco WA 6008
Country 60230 0
Phone 60230 0
+6189340 2222
Fax 60230 0
Email 60230 0
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
Phone 60231 0
+6189340 2222
Fax 60231 0
Email 60231 0
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
Phone 60232 0
+6189340 2222
Fax 60232 0
Email 60232 0

No information has been provided regarding IPD availability
Summary results
No Results