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

Primary Lung Graft Dysfunction Clinical Trial

— ETO VD PERIOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887560
• Other study ID #: 6283
• Status: Completed
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: February 27, 2018

Study information

• Verified date: March 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 27, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Lung Graft Dysfunction

Intervention

Procedure:
• transoesophageal echocardiography

Locations

Country	Name	City	State
France	Strasbourg's New Civil Hospital, Cardiac surgical reanimation department	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.