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

Reperfusion Injury After Pulmonary Thromboendarterektomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806504
• Other study ID #: 2018/6/62
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2021
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Reperfusion Injury
• Reperfusion Injury After Pulmonary Thromboendarterektomy

Intervention

Other:
• PEEP
performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume
• control group
performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume

Locations

Country	Name	City	State
Turkey	Mustafa EMRE Gurcu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours
Secondary	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	10 day