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

Not Applicable

Completed

• Conditions: Reperfusion Injury After Pulmonary Thromboendarterektomy
• Interventions: Other: PEEP; Other: control group

• Registration Number: NCT03806504
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high PEEP	PEEP	35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass
control group	control group	6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
free oxygen radicals levels	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
postoperatif outcome - Duration of stay in the intensive care unit and hospital stay	10 day	Duration of stay in the intensive care unit and hospital stay after pte operation

Trial Locations

Locations (1)

Mustafa EMRE Gurcu; 🇹🇷 Istanbul, Turkey