Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0391148230
Study information
Scientific title
Acronym
Study hypothesis
Null hypothesis: that there will be no difference in the expired oxygen concentration.
Ethics approval
Not provided at time of registration
Study design
Cross over randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/09/2004
Overall trial end date
31/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Between 20-30 subjects recruited from non-anaesthetic colleagues.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30 healthy volunteers recruited from colleagues
Participant exclusion criteria
Respiratory disease, significant cardiac disease.
Recruitment start date
01/09/2004
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Dorset General Hospitals NHS Trust
Dorchester
DT1 2JY
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
West Dorset General Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17444313
Publication citations
-
Results
Ball AJ, Craig J, Green RJ, Richardson DJ, Performance comparison of two anaesthetic facemasks., Anaesth Intensive Care, 2007, 35, 2, 226-229.