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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Ischemic-reperfusion Injury During Cardiopulmonary Bypass - Substudy of NCT00997217

Conditions
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Acute Lung Injury

Intervention / Treatment
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* Procedure: remote ischemic preconditioning and postconditioning
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC<br>those who receive RIPC and RIPoC before and after CPB | Procedure: remote ischemic preconditioning and postconditioning<br>* RIPC is done before the use of CPB. It consists of 4 cycles of 5 minutes inflation of pneumatic cuff to 200 mmHg and deflation for 5 minutes. RIPoC is exactly same procedure done after CPB.<br>|
| Placebo Comparator: Control<br>this group have same pneumatic cuff around their arm, but it is not inflated. | Procedure: Control<br>* This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial partial pressure of oxygen divided by fraction of inspired oxygen | follow up PaO2/FiO2 during operation and after the opreation for 24 hours | within 24hr after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma cytokines | follow up plasma IL-6, IL-8, IL-10, TNF-alpha levels during the surgery and within 24hr after the surgery | within 24hr after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RIPC, lung protection, ischemic reperfusion injury, cardiopulmonary bypass