Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0065101825
Study information
Scientific title
Acronym
Study hypothesis
Does positioning a patient in a reclined versus a supine position before pre-oxygenation improve the efficacy of this process? Primary null hypothesis is that positioning a patient 20 head-up will not effect the efficacy of pre-oxygenation.
Ethics approval
Not provided at time of registration
Study design
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: Cholecystomy
Intervention
20 women will be randomised to receive oxygen in the usual way.
20 women will receive oxygen in a slightly reclined position.
Monitors will be used to determine which group of patients demonstrates the most oxygen stored in their body. Patients will be connected to a breathing machine via a tube placed in their throat after they are asleep. The study also aims to investigate which position (lying flat or slightly reclined) provides the best view of the patient's throat when placing the tube.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2001
Overall trial end date
01/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
40 female patients undergoing cholecystomy.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
40
Participant exclusion criteria
Pregnant patients will be excluded.
Recruitment start date
01/11/2001
Recruitment end date
01/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
City Hospitals Sunderland NHS Trust (UK)
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
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16229689
Publication citations
-
Results
Lane S, Saunders D, Schofield A, Padmanabhan R, Hildreth A, Laws D, A prospective, randomised controlled trial comparing the efficacy of pre-oxygenation in the 20 degrees head-up vs supine position., Anaesthesia, 2005, 60, 11, 1064-1067, doi: 10.1111/j.1365-2044.2005.04374.x.