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

K

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Status

Completed

Conditions

Reperfusion Injury After Pulmonary Thromboendarterektomy

Treatments

Other: PEEP
Other: control group

Study type

Interventional

Funder types

Other

Identifiers

NCT03806504
2018/6/62

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

high PEEP
Active Comparator group
Description:
35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass
Treatment:
Other: PEEP
control group
Active Comparator group
Description:
6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass
Treatment:
Other: control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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