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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03806504
Enrollment
60
Registered
2019-01-16
Start date
2019-01-01
Completion date
2019-12-31
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reperfusion Injury After Pulmonary Thromboendarterektomy

Keywords

Chronic thromboembolic pulmonary hypertension, PEEP, reperfusion injury

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.

Interventions

OTHERPEEP

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

OTHERcontrol group

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

Sponsors

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

prospective, randomized

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
free oxygen radicals levels48 hoursSuperoxide 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

MeasureTime frameDescription
postoperatif outcome - Duration of stay in the intensive care unit and hospital stay10 dayDuration of stay in the intensive care unit and hospital stay after pte operation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026