CClinicalTrials.gg
CompletedNCT02887560ETO VD PERIOPUpdated Mar 7, 2019

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

An interventional study of transoesophageal echocardiography in Primary Lung Graft Dysfunction, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Lung Graft Dysfunction

Browse trials for

Keywords

  • Right ventricle
  • Pulmonary transplantation
  • Strain
  • isovolumic acceleration (IVA)
03

In context

Systolic Murmurs

146 studies on the registry are indexed under Systolic Murmurs; 17 are open to participants now.

This study's enrollment of 33 is below the median of 93 across 87 interventional studies indexed under Systolic Murmurs.

Browse Systolic Murmurs studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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: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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • 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

Interventions

  • Proceduretransoesophageal echocardiography
06

What researchers measure

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.

07

Study locations

1 site
  • Strasbourg's New Civil Hospital, Cardiac surgical reanimation department
    Strasbourg, 67091, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02887560
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Sep 2, 2016
Start date
Dec 5, 2016
Primary completion
Feb 20, 2018
Completion
Feb 27, 2018
Last update
Mar 7, 2019

Study contacts

Gharib Ajob, MD
principal investigator · Strasbourg's University Hospitals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion