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

NCT ID: NCT02887560

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2018-02-27

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.

Conditions

Primary Lung Graft Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

All patient

Only one arm has been specified for the protocol. This arm included all study patient (33) for which the intervention is to be administered

Group Type: EXPERIMENTAL

transoesophageal echocardiography

Intervention Type: PROCEDURE

Interventions

transoesophageal echocardiography

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gharib Ajob, MD

Role: PRINCIPAL_INVESTIGATOR

Strasbourg's University Hospitals

Locations

Strasbourg's New Civil Hospital, Cardiac surgical reanimation department

Strasbourg, , France

Countries

France

Other Identifiers

6283

Identifier Type: -

Identifier Source: org_study_id