Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000126718
Ethics application status
Approved
Date submitted
31/01/2013
Date registered
1/02/2013
Date last updated
1/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The anaesthesia pre-oxygenation trial - using O2 Flush and Nasal oxygen for pre-oxygenation compared to traditional methods.
Scientific title
The effect of anaesthesia pre-oxygenation with O2 flush and nasal prongs on end tidal O2 in healthy adult volunteers
Secondary ID [1] 281874 0
NIL
Universal Trial Number (UTN)
U1111-1139-1075
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia preoxygenation 288258 0
Condition category
Condition code
Anaesthesiology 288610 288610 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participants will perform repeated pre oxygenation in a computer generated randomised fashion.

With a good mask seal
1. Standard - Anaesthesia machine (15L/min)
2. Standard PLUS nasal prong oxygenation
3. Standard PLUS anaesthesia machine oxygen flush

With simulated face mask leak
4. Standard
5. Standard PLUS nasal prong oxygenation
6. Standard PLUS anaesthesia machine oxygen flush


Each of these interventions will be assess using deep breathing for 90 seconds and tidal breathing for 3 minutes.

The wash out period will be a minimum of 3 minutes and until the end tidal O2 is less than 20%
Intervention code [1] 286436 0
Treatment: Other
Comparator / control treatment
Control is standard preoxygenation with anaesthesia machine (with and with out a simulated mask leak)
Control group
Active

Outcomes
Primary outcome [1] 288762 0
End tidal O2 (exhaled breath oxygen content) as measure by standard anaesthesia machine
Timepoint [1] 288762 0
Immediately post preoxygenation
Secondary outcome [1] 300923 0
Tolerance on a verbal analogue scale (0-10)
Timepoint [1] 300923 0
Immediately post preoxygenation

Eligibility
Key inclusion criteria
1. Age 18 and over
2. Healthy volunteers
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Refusal or withdrawal of consent at any stage
2. 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)
Participants will be recruited by a junior member of staff

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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of the primary outcome will be conducted using general linear model procedures accounting for the crossover design of the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2013
Actual
10/01/2013
Date of last participant enrolment
Anticipated
10/05/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 524 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 6262 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 286660 0
Hospital
Name [1] 286660 0
King Edward Memorial Hospital
Country [1] 286660 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] 285438 0
None
Name [1] 285438 0
Address [1] 285438 0
Country [1] 285438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288731 0
King Edward Memorial Hospital for Women (KEMH) Ethics & Research Governance
Ethics committee address [1] 288731 0
GPO Box D184
Perth
WA
6840
Ethics committee country [1] 288731 0
Australia
Date submitted for ethics approval [1] 288731 0
Approval date [1] 288731 0
Ethics approval number [1] 288731 0
2049/EW

Summary
Brief summary
Prior to general anaesthesia the standard of care is to pre-oxygenation all patients. This involves the patient breathing 100% oxygen via a face mask.

The 3 most common methods of pre oxygenation involve 4 deep breaths over 30 seconds, 8 deep breaths over 60 seconds or 3 minutes of tidal volume breathing (normal breathing) using high flow 100% oxygen (15L per minute via the anaesthesia machine with a face mask).

The most common reasons for poor preoxygenation is an inadequate face mask seal resulting in the patient breathing room air (low oxygen content) through the leak.

Nasal oxygen and the anaesthesia machine oxygen flush delivery higher flow rates than the standard method by the the anaesthesia machine so may reduce the amount of inspired air from the leak.

Study Hypothesis - High flow oxygen with nasal oxygen or anaesthesia machine oxygen flush produces higher end tidal oxygen levels (better pre oxygenation) in the simulated mask leak scenario.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37514 0
Dr Twain Russell
Address 37514 0
King Edward Memorial Hospital
374 Bagot rd
Subiaco
WA
6008
Country 37514 0
Australia
Phone 37514 0
+61 (08) 9340 2222
Fax 37514 0
Email 37514 0
twain.russell@health.wa.gov.au
Contact person for public queries
Name 37515 0
Twain Russell
Address 37515 0
King Edward Memorial Hospital
374 Bagot rd
Subiaco
WA
6008
Country 37515 0
Australia
Phone 37515 0
+61 (08) 9340 2222
Fax 37515 0
Email 37515 0
twain.russell@health.wa.gov.au
Contact person for scientific queries
Name 37516 0
Twain Russell
Address 37516 0
King Edward Memorial Hospital
374 Bagot rd
Subiaco
WA
6008
Country 37516 0
Australia
Phone 37516 0
+ 61 (08) 9340 2222
Fax 37516 0
Email 37516 0
twain.russell@health.wa.gov.au

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
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Documents added automatically
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