NCT03806504

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

January 15, 2019

Last Update Submit

May 6, 2021

Conditions

Reperfusion Injury After Pulmonary Thromboendarterektomy

Keywords

Chronic thromboembolic pulmonary hypertensionPEEPreperfusion injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • postoperatif outcome - Duration of stay in the intensive care unit and hospital stay

    10 day

Study Arms (2)

high PEEP

ACTIVE COMPARATOR

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

Other: PEEP

control group

ACTIVE COMPARATOR

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

Other: control group

Interventions

PEEPOTHER

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

high PEEP
control groupOTHER

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

control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective PTE operation due to CTEPH,
  • years old

You may not qualify if:

  • Patients with chronic inflammatory disease,
  • liver and renal failure,
  • heart failure (\<EF: 40%),
  • intraoperative bronchial hemorrhage,
  • patients undergoing postoperative revision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa EMRE Gurcu

Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: prospective, randomized
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesia and reanimation specialist

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 16, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

TU(1)