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

NCT ID: NCT03806504

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Reperfusion Injury After Pulmonary Thromboendarterektomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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high PEEP

35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

PEEP

Intervention Type OTHER

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

control group

6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

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

Interventions

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PEEP

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

Intervention Type OTHER

control group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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mustafa emre gürcü

anesthesia and reanimation specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mustafa EMRE Gurcu

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018/6/62

Identifier Type: -

Identifier Source: org_study_id

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