To investigate whether during cardiac surgery with cardiopulmonary bypass the lungs are better protected from injury if they receive low frequency ventilation.

ISRCTN	ISRCTN75795633
DOI	https://doi.org/10.1186/ISRCTN75795633
Secondary identifying numbers	CS/2009/3259

Submission date: 09/06/2010
Registration date: 16/06/2010
Last edited: 30/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Raimondo Ascione
Scientific

Bristol Heart Institute
Level 7
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Study information

Study design	Single-centre parallel-group open randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information leaflet
Scientific title	Pulmonary protection with low frequency ventilation during cardiac surgery with cardiopulmonary bypass: a randomised controlled trial
Study acronym	PROTECTION 1
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/09/2010
Completion date	01/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	60
Total final enrolment	63
Key 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%
Key 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
Date of first enrolment	01/09/2010
Date of final enrolment	01/09/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bristol Heart Institute

Level 7
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor information

University Hospitals Bristol NHS Foundation Trust
Hospital/treatment centre

Research and Development Department
Education Centre Level 3
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom

"ROR"	https://ror.org/04nm1cv11

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		30/09/2024	30/09/2024	Yes	No

Editorial Notes

30/09/2024: Publication reference and total final enrolment added.
20/03/2018: No publications found, verifying study status with principal investigator
05/02/2016: No publications found, verifying study status with principal investigator