Back to resultsHigh PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?
Primary Purpose
Reperfusion Injury After Pulmonary Thromboendarterektomy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PEEP
control group
Sponsored by
About this trial
This is an interventional prevention trial for Reperfusion Injury After Pulmonary Thromboendarterektomy focused on measuring Chronic thromboembolic pulmonary hypertension, PEEP, reperfusion injury
Eligibility Criteria
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.
Sites / Locations
- Mustafa EMRE Gurcu
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
high PEEP
control group
Arm Description
35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass
6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass
Outcomes
Primary Outcome Measures
free oxygen radicals levels
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 Outcome Measures
postoperatif outcome - Duration of stay in the intensive care unit and hospital stay
Duration of stay in the intensive care unit and hospital stay after pte operation
Full Information
NCT ID
NCT03806504
First Posted
January 15, 2019
Last Updated
May 6, 2021
Sponsor
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03806504
Brief Title
High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?
Official Title
Prospective Randomized Trial of Impact of High PEEP Application Following Pulmonary Endarterectomy on Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury After Pulmonary Thromboendarterektomy
Keywords
Chronic thromboembolic pulmonary hypertension, PEEP, reperfusion injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high PEEP
Arm Type
Active Comparator
Arm Description
35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass
Arm Title
control group
Arm Type
Active Comparator
Arm Description
6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass
Intervention Type
Other
Intervention Name(s)
PEEP
Intervention Description
performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume
Primary Outcome Measure Information:
Title
free oxygen radicals levels
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
postoperatif outcome - Duration of stay in the intensive care unit and hospital stay
Description
Duration of stay in the intensive care unit and hospital stay after pte operation
Time Frame
10 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mustafa EMRE Gurcu
City
Istanbul
ZIP/Postal Code
34865
Country
Turkey
12. IPD Sharing Statement
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High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?
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