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Clinical Trials/NCT03806504
NCT03806504
Completed
Not Applicable

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

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital1 site in 1 country60 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Reperfusion Injury After Pulmonary Thromboendarterektomy
Sponsor
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Enrollment
60
Locations
1
Primary Endpoint
free oxygen radicals levels
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

mustafa emre gürcü

anesthesia and reanimation specialist

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

free oxygen radicals levels

Time Frame: 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 Outcomes

  • postoperatif outcome - Duration of stay in the intensive care unit and hospital stay(10 day)

Study Sites (1)

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