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

May 6, 2021 updated by: mustafa emre gürcü, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34865
        • Mustafa Emre Gurcu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/6/62

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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