Comparison of anaesthetic face masks - a crossover trial to compare air entrainment using the standard BOC mask vs the intersurgical single use mask during preoxygenation

ISRCTN	ISRCTN45706447
DOI	https://doi.org/10.1186/ISRCTN45706447
Secondary identifying numbers	N0391148230

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Andy Ball
Scientific

West Dorset General Hospitals NHS Trust
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Study design	Cross over randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Null hypothesis: that there will be no difference in the expired oxygen concentration.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	20 to 30 subjects randomised into 2 groups. Each group will undergo 2 cycles of 3 minutes preoxygenation with each of the test masks, attached to the same anaesthetic circuit.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Comparison of area under the curve for expired oxygen concentration against time over 3 minutes. 2. Comparison of inspired oxygen concentrations against time over the 3 minutes.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2004
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	30 healthy volunteers recruited from colleagues
Key inclusion criteria	Between 20-30 subjects recruited from non-anaesthetic colleagues.
Key exclusion criteria	Respiratory disease, significant cardiac disease.
Date of first enrolment	01/09/2004
Date of final enrolment	31/03/2005

West Dorset General Hospitals NHS Trust

Dorchester
DT1 2JY
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

West Dorset General Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No