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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201212000470185 Date registered: 2012/12/11
TRIAL DESCRIPTION
Public title The effects of a lung recruitment manoeuvre before extubation on pulmonary function after coronary artery bypass surgery.
Official scientific title A Pre-extubation Recruitment Maneuver is Safe and Improves Lung Compliance in a Cardiac Surgery Population
Brief summary describing the background
and objectives of the trial
Cardiac surgery results in major changes in the structure and function of the respiratory system.These changes may persist up to 4 months post surgery. The aim of this study is to determine if the addition of a pre-extubation recruitment maneuver to standard care is safe and will improve lung compliance and subsequent PaO2/FiO2 (PF ratio) after extubation in postoperative coronary artery bypass graft surgery patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2010-07-18
Actual trial start date 2010-10-03
Anticipated date of last follow up 2011-09-30
Actual date of last follow up 2011-11-22
Anticipated target sample size (number of participants) 72   
Actual target sample size (number of participants) 47   
Recruitment status Terminated
Secondary Ids Issuing authority/Trial register Links to Secondary ID
N07/07/159 Stellenbosch University Ethics Committee

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Lung recruitment maneuver two recruitment maneuvers with a15 min interval 21 min Dräger Savina 2 (BIPAP).Initially a gradual incremental increase of PEEP every 5 breaths were done. When a PEEP of 15 cmH2O was reached the IP was incrementally increased to 15 cmH2O above PEEP. After 5 breaths at 30cmH2O, two consecutive inspiratory holds of 15s each was applied. After another 5 breaths the IP and PEEP was then decreased incrementally every 5 breaths back to pre-RM settings. 22 Placebo
Control group sham intervention two sham recruitment maneuvers with a 15 min interval 21 min The principle investigators spend the same amount of time and gave similar instructions at the control patient¿s bedside (behind closed curtains) without actively recruiting the lungs 25

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
adult patients admitted for uncomplicated elective coronary artery bypass graft (CABG) surgery preoperatively: valve replacement in addition to CABG previous cardiac surgery COPD with bullae (CXR) postopratively: no arterial line in situ intra-operative pulmonary trauma and/or bleeding (>100ml/h) decreased arterial systolic pressure (< 80 mmHg) and/or mean arterial pressure (< 60 mmHg) intubation time more than 14 hours on a itra-aortic ballon pump (IABP) 18 Years 100 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2010/07/18 Research Committee Network Healthcare Holdings Limited (Netcare)
Ethics Committee Address
Street address City Postal code Country
76 Maude street, corner West street Sandton 2010 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PaO2/FiO2 preoperatively on ICU arrival pre recruitment maneuver 1 hour post extubation 6 hours post extubation 12 hours post extubation 18 hours post extubation 24 hours post extubation
Secondary Outcome static lung compliance on ICU arrival pre recruitment maneuver more than 5 min post recruitment maneuver before extubation
Secondary Outcome adverse events during recruitment maneuver contineously up to 5 min after recruitment maneuver

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kuilsriver Hospital 33 Van Riebeeck street Kuilsriver 7579 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Stellenbosch University Francie van Zyl Tygerberg 7500 South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University Francie van Zyl Tygerberg 7500 South Africa University

COLLABORATORS
Name Street address City Postal code Country
Dr SD Hanekom Francie van Zyl Tygerberg 7500 South Africa
Proff A Coetzee Francie van Zyl Tygerberg 7500 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Scientific Enquiries Dr Susan Hanekom sdh@sun.ac.za +27 219389496 +27 219311252
Street address City Postal code Country Position / Affiliation
Francie van Zyl Tygerberg 7500 South Africa Senior lecturer
Role Name Email Phone Fax
Principal Investigator Mr Stephanus G Nel stephangnel@gmail.com +27 832549124 +27 219006773
Street address City Postal code Country Position / Affiliation
Francie van Zyl Tygerberg 7500 South Africa post graduate student
Role Name Email Phone Fax
Public Enquiries Mr Stephanus G Nel stephangnel@mail.com +27 832549124 +27 219006773
Street address City Postal code Country Position / Affiliation
Francie van Zyl Tygerberg 7500 South Africa post graduate student