Condition category
Surgery
Date applied
09/06/2010
Date assigned
16/06/2010
Last edited
05/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Raimondo Ascione

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/02/2016: No publications found, verifying study status with principal investigator