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

NCT02887560 | Completed

• 1 other identifier: 6283
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Transesophageal echocardiographic assessment for comparision of right ventricle free-wall strain rate in perioperative care of bipulmonary transplantation

  Outcome 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 transplantation

  utcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.

Study Arms (1)

All patient

EXPERIMENTAL

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

Procedure: transoesophageal echocardiography

Interventions

transoesophageal echocardiography PROCEDURE

All patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Minor patients
• Patient under judicial protection, under guardianship
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Strasbourg's New Civil Hospital, Cardiac surgical reanimation department

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Gharib Ajob, MD

  Strasbourg's University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: September 2, 2016
• Study Start: December 5, 2016
• Primary Completion: February 20, 2018
• Study Completion: February 27, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)