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

Not Applicable

Completed

• Conditions: Coronary artery and or valvular disease; Surgery

• Registration Number: ISRCTN75795633
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39344668/ (added 30/09/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-16
• Study Completion: 2013-09-01
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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%

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Release of inflammatory mediators: 1. Thromboxane A22. TNFa 3. IL-1ß4. IL-65. 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

Name	Time	Method
1. Measurement of oxidative stress from left atrial and right atrial blood sampling post-cannulation, before institution of CPB and on weaning from CPB2. Pulmonary function tests carried out before surgery, at hospital discharge, and at 6-8 weeks post surgery3. Pulmonary gas exchange measured post-induction and pre-sternotomy, 10 minutes following CPB weaning, 2 and 6 hours post CPB weaning4. Respiratory system and lung mechanics measured on arrival on ICU, 2 and 6 hors post CPB weaning5. Intrapulmonary shunt fraction measured post-induction and pre-sternotomy, 10 minutes following CPB weaning, and before chest closure6. Pulmonary trapping of white blood cells measured post-cannulation, before institution of CPB and on weaning from CPB7. A composite endpoint of lung-related complications8. The time until patients are classified as fit for discharge