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Completed

NCT Number: NCT03806504

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

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

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Key information

Conditions

Reperfusion Injury After Pulmonary Thromboendarterektomy Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mustafa EMRE Gurcu

Istanbul, 34865, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEEP

Other

performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume

Control Group

Other

performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume

Primary outcomes

  1. 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

  1. postoperatif outcome - Duration of stay in the intensive care unit and hospital stay

    Time frame: 10 day

    Duration of stay in the intensive care unit and hospital stay after pte operation

Sponsors and collaborators

Lead sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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