High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?

Study Overview
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Brief Summary
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Investigation of the effect of intraoperative lung protection high PEEP maneuver on ischemic reperfusion injury in patients undergoing pulmonary endarterectomy.

Detailed Description
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Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterized by progression of thromboembolism obstructing pulmonary arteries as an organized tissue. Pulmonary thromboendarterectomy (PTE) is a treatment option for chronic thromboembolic pulmonary disease. However, PTE is associated with specific postoperative complications, such as pulmonary edema and right ventricular failure due to reperfusion injury, with a significant mortality rate of 7% to 24%. Some strategies have been proposed to reduce lung injury after PTE, such as rectification maneuvers and high PEEP. The aim of this study was to investigate the effect of intraoperative lung protection high PEEP maneuver in patients undergoing pulmonary endarterectomy for ischemic reperfusion injury.

Official Title
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Prospective Randomized Trial of Impact of High PEEP Application Following Pulmonary Endarterectomy on Outcome

Conditions
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Reperfusion Injury After Pulmonary Thromboendarterektomy

Intervention / Treatment
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* Other: PEEP
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective PTE operation due to CTEPH, 20-70 years old Exclusion Criteria: Patients with chronic inflammatory disease, liver and renal failure, heart failure (<EF: 40%), intraoperative bronchial hemorrhage, patients undergoing postoperative revision.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Interventional Model Description: prospective, randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high PEEP<br>35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass | Other: PEEP<br>* performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume<br>|
| Active Comparator: control group<br>6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass | Other: control group<br>* performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free oxygen radicals levels | Superoxide dismutase (SOD) activity will be measured by modification of the method of Sun et al. and Protein carbonyl groups will be determined by volume modification according to Reznick and Packer method. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperatif outcome - Duration of stay in the intensive care unit and hospital stay | Duration of stay in the intensive care unit and hospital stay after pte operation | 10 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic thromboembolic pulmonary hypertension, PEEP, reperfusion injury