Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CS/2009/3259
Study information
Scientific title
Pulmonary protection with low frequency ventilation during cardiac surgery with cardiopulmonary bypass: a randomised controlled trial
Acronym
PROTECTION 1
Study hypothesis
During conventional open-heart surgery the heart is stopped, most of the blood supply is diverted from the heart and lungs to the heart-lung machine (known as cardiopulmonary bypass) and the lungs are disconnected from the ventilator and left open to air. Cardiopulmonary bypass is known to be associated with major injury to the heart and lungs. The hypothesis for this study is that ventilating the lungs at low frequency rate will prevent significant injury to the lungs.
Ethics approval
Not provided at time of registration
Study design
Single centre parallel group open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information leaflet
Condition
Coronary artery and or valvular disease
Intervention
Control group: during cardiopulmonary bypass the lungs will be disconnected from ventilator and left open to air (i.e. usual care).
Intervention group: during cardiopulmonary bypass the lungs will be ventilated at low frequency rate (5/min with air (21% oxygen) at a tidal volume of 6-8 ml/Kg).
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Release of inflammatory mediators:
1. Thromboxane A2
2. TNFα
3. IL-1β
4. IL-6
5. IL-10
Measured in plasma samples taken at post-induction and pre-sternotomy, 10 minutes following CPB weaning, and 2, 6, 12, and 24 hours post CPB weaning.
Secondary outcome measures
1. Measurement of oxidative stress from left atrial and right atrial blood sampling post-cannulation, before institution of CPB and on weaning from CPB
2. Pulmonary function tests carried out before surgery, at hospital discharge, and at 6-8 weeks post surgery
3. Pulmonary gas exchange measured post-induction and pre-sternotomy, 10 minutes following CPB weaning, 2 and 6 hours post CPB weaning
4. Respiratory system and lung mechanics measured on arrival on ICU, 2 and 6 hors post CPB weaning
5. Intrapulmonary shunt fraction measured post-induction and pre-sternotomy, 10 minutes following CPB weaning, and before chest closure
6. Pulmonary trapping of white blood cells measured post-cannulation, before institution of CPB and on weaning from CPB
7. A composite endpoint of lung-related complications
8. The time until patients are classified as fit for discharge
Overall trial start date
01/09/2010
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >16 and <80 years
2. Undergoing any elective or urgent coronary artery bypass grafting (CABG) with >3 grafts, valve, or CABG+Valve adult cardiac surgery procedure with cardiopulmonary bypass and cardioplegic arrest
3. Left ventricular ejection fraction > 25%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Previous pulmonary embolism requiring long term warfarin for > 3 months
2. Previous cardiac surgery
3. Current congestive heart failure (NYHA class IV)/cardiogenic shock
4. Chronic renal failure requiring dialysis
5. Emergency or salvage operation
6. On corticosteroid or immunosuppressive treatment
Recruitment start date
01/09/2010
Recruitment end date
01/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Heart Institute
Level 7
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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