Low Frequency Ventilation during cardiopulmonary bypass for lung protection

Low Frequency Ventilation during cardiopulmonary bypass for lung protection: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34428459

Enrollment

Registered

2012-05-16

Start date

2012-06-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Open-heart surgery with CPB / coronary artery bypass grafting (CABG) Surgery

Interventions

Participants will be randomised to LFV or control group Low frequency ventilation (Experimental treatment) In the LFV group, lung ventilation will be maintained for the entire duration of CPB using

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A participant may enter the study if ALL of the following apply: 1. Age =40 and 30%

Exclusion criteria

Exclusion criteria: A participant may not enter the study if ANY of the following apply: 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 7. Severe chronic obstructive pulmonary disease (COPD), lung pathology and previous radiotherapy 8. Body mass index (BMI) >35

Design outcomes

Primary

Measure	Time frame
NF-kB p65 activation measured in lung biopsies	—

Secondary

Measure	Time frame
1. In the lung biopsies: 1.1. p38 MAPK phosphorylation by Enzyme-linked immunosorbent assay (ELISA) and Western blotting (41-42) 1.2. Expression of TNFa, IL-1b, IL-18, IL-6, IP-10 and IL-8 and IL-10 by real-time polymerase chain reaction (PCR) and ELISA 1.3. Caspase 3 as a marker of apoptosis 2. In peripheral blood samples: 2.1. Reactive oxygen species (ROS) levels 2.2. Phosphorylation of p38 (Thr180/Tyr182) and NF-kB p65 (Ser529) 3. Pulmonary function tests (PFTs) 4. Pulmonary gas exchange 5. Adverse events	—

Measure

Time frame

1. In the lung biopsies: 1.1. p38 MAPK phosphorylation by Enzyme-linked immunosorbent assay (ELISA) and Western blotting (41-42) 1.2. Expression of TNFa, IL-1b, IL-18, IL-6, IP-10 and IL-8 and IL-10 by real-time polymerase chain reaction (PCR) and ELISA 1.3. Caspase 3 as a marker of apoptosis 2. In peripheral blood samples: 2.1. Reactive oxygen species (ROS) levels 2.2. Phosphorylation of p38 (Thr180/Tyr182) and NF-kB p65 (Ser529) 3. Pulmonary function tests (PFTs) 4. Pulmonary gas exchange 5. Adverse events

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026