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Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.

Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02887560
Acronym
ETO VD PERIOP
Enrollment
33
Registered
2016-09-02
Start date
2016-12-05
Completion date
2018-02-27
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Lung Graft Dysfunction

Keywords

Right ventricle, Pulmonary transplantation, Strain, isovolumic acceleration (IVA)

Brief summary

The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation. Secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.

Interventions

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult (over 18 years) * Patient affiliated to a social protection scheme insurance * Patient was informed of the study and w gave their consent * Patient on the lung transplant list * Patient eligible for a pulmonary transplantation after decision of a multidisciplinary team * Patients with chronic lung disease with parenchymal dysfunctions (Chronic obstructive pulmonary disease or COPD, alpha-1 antitrypsin deficiency, cystic fibrosis, pulmonary fibrosis, bronchiolitis obliterans organizing pneumonia or BOOP)

Exclusion criteria

d * Minor patients * Patient under judicial protection, under guardianship * Patient in exclusion period (determined by a previous study or in progress) * Patient participating in parallel in another clinical trial that may interfere with the results of the study * Inability to give informed patient information (emergency, understanding difficulties, etc ...) * The refusal of patient consent * The use of cardiopulmonary bypass during lung transplantation * Uni-pulmonary transplant * A transplant for idiopathic or primary pulmonary hypertension * The presence of a cons-indication for transesophageal echocardiography: o Absolute contraindications: * Abnormalities of the esophagus: stenosis, tumor, diverticulum perforation, active bleeding o Relative contraindications: * ancient cervicothoracic irradiation history (\> 10 years) * recent upper gastrointestinal bleeding history * presence of esophageal varices ≥ grade II * zero cervical mobility * Reflux Esophagitis * Severe coagulation disorders * Pregnancy / Breastfeeding

Design outcomes

Primary

MeasureTime frame
Transesophageal echocardiographic assessment for comparision of right ventricle free-wall strain rate in perioperative care of bipulmonary transplantationOutcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.
Transesophageal echocardiographic assessment for comparision of right ventricle isovolumic acceleration in perioperative care of bipulmonary transplantationutcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026