Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436146556
Study information
Scientific title
Acronym
Study hypothesis
Using alveolar recruitment strategies in the immediate post operative period following cardiopulmonary bypass improves lung function as displayed by an increase in arterial oxygenation. This may therefore reduce post operative complications. i.e pneumonia and reduce time sedated on intensive care.
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiopulmonary bypass surgery
Intervention
Randomised controlled trial
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
To increase arterial oxygenation
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2003
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Elective coronary artery bypass and uncomplicated aortic root surgery through a median sternotomy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
28 patients in each arm of the study
Participant exclusion criteria
Patient refusal, pre-existing lung disease, mitral valve disease, known pulmonary hypertension, chronic renal failure, morbid obesity or emergency surgery.
Recruitment start date
01/12/2003
Recruitment end date
01/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetic Dept
Leeds
LS1 3EX
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
Leeds Teaching 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
Results - basic reporting
Publication summary