Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant. (ETO VD PERIOP)

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.

Study Overview

• Status: Completed
• Conditions: Primary Lung Graft Dysfunction
• Intervention / Treatment: Procedure: transoesophageal echocardiography

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Strasbourg's New Civil Hospital, Cardiac surgical reanimation department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: transoesophageal echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Gharib Ajob, MD, Strasbourg's University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): February 20, 2018
• Study Completion (Actual): February 27, 2018

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Right ventricle; Strain; Pulmonary transplantation; isovolumic acceleration (IVA)
• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs
• Other Study ID Numbers: 6283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO