Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Injury During Cardiopulmonary Bypass

Seoul National University

Status

Completed

Conditions

Acute Lung Injury

Treatments

Procedure: Control

Procedure: remote ischemic preconditioning and postconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT01144585

H-1001-016-306

Details and patient eligibility

About

Remote Ischemic Preconditioning(RIPC) and remote ischemic postconditioning(RIPoC) seems to have a protective effect during ischemic period. Using cardiopulmonary bypass(CPB) during open heart surgery reduces pulmonary blood flow and may cause ischemic damage to lung tissue. The investigators anticipate that RIPC and RIPoC may reduce lung injury after CPB.

Full description

Cardiopulmonary bypass(CPB) can cause lung function deterioration through various mechanisms. Lung parenchymal tissue ischemia resulted by pulmonary atelectasis and decreased bronchial circulation during CPB is one of the reasons. There were few studies reported that RIPC and RIPoCcan benefit lung function of children or infant after CPB, but studies about adults are still lacking.

Purpose:

The purpose of this study is to evaluate effect of RIPC and RIPoC on the lung function after CPB.

Methods:

Patients will randomly allocated either in study group or control group. Study group will receive RIPC and RIPoC maneuver before and after CPB. Control group will have same automated cuff around their arm but it will not activated. Care givers will be blinded whether the automated cuff is on or not.

We will compare pulmonary parameters (PaO2/FiO2, dynamic and static compliances, Intrapulmonary shunts, etc.) between study group and control group, and check levels of plasma cytokines(IL-4, IL-8, IL-10, TNF-alpha) till 24hr after the operation.

Enrollment

76 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

those who aged 18-80 years old and planned to undergo elective open heart surgery using cardiopulmonary bypass

Exclusion criteria

emergent operation
preoperative use of inotropics or mechanical assist device,
left ventricular ejection fraction less than 30%,
severe liver, renal disease,
recent myocardial infarction (within 7 days),
recent systemic infection or sepsis (within 7 days)
peripheral vascular disease affecting upper limbs
amputation of the upper limbs
major combined operation such as aortic surgery or carotid endarterectomy
descending thoracic aortic surgery
rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc
significantly decreased pulmonary function before the planned surgery (e.g. using ventilator, oxygen therapy, tachypnea, orthopnea, active lung lesion on chest X-ray, FEV1/FVC less than 50% of predicted level, PaO2 less than 80 mmHg)
intracardiac shunt
severe pulmonary artery hypertension
systemic or local steroid therapy