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OpenTrials
Completed

NCT Number: NCT02887560

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Strasbourg's New Civil Hospital, Cardiac surgical reanimation department

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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  • 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

Treatment and study plan

Transoesophageal echocardiography

Procedure

Primary outcomes

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

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

  2. Transesophageal echocardiographic assessment for comparision of right ventricle isovolumic acceleration in perioperative care of bipulmonary transplantation

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ETO VD PERIOP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 2, 2016
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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