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

Pulmonary protection with low frequency ventilation during cardiac surgery with cardiopulmonary bypass: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75795633

Enrollment

Registered

2010-06-16

Start date

2010-09-01

Completion date

Unknown

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery and or valvular disease Surgery

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >16 and 3 grafts, valve, or CABG+Valve adult cardiac surgery procedure with cardiopulmonary bypass and cardioplegic arrest 3. Left ventricular ejection fraction > 25%

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Release of inflammatory mediators: 1. Thromboxane A2 2. TNFa 3. IL-1ß 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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026