Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation (DIATRIB)

June 5, 2019 updated by: Centre Chirurgical Marie Lannelongue

A current complication after lung transplantation is diaphragmatic dysfunction. These dysfunction result to several factors: duration of mechanical ventilation, chest tube, atelectasis, denutrition, phrenic nerve injury during surgical dissection… Only monocentric and retrospective studies collected diaphragmatic paralysis after lung transplant are published. The incidence of diaphragmatic paralysis in post-operative lung transplantation varies from 3.2% to 16.8%.

The main hypothesis of the study is to defined the incidence of diaphragmatic dysfunction in post-operative lung transplantation.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Thibaut GENTY, MD
  • Phone Number: 0140942260
  • Email: t.genty@hml.fr

Study Locations

  • France
      • Le Plessis-Robinson, France, 92350
        • Recruiting
        • Centre Chirurgical Marie Lannelongue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient in immediate postoperative bi-pulmonary transplantation

Description

Inclusion Criteria:

  • Adults (≥ 18 years old)
  • Admitted for intensive care that can be spontaneously ventilated after bi- pulmonary transplantation

Exclusion Criteria:

  • Minor patient
  • Ventilated patients less than 24 hours
  • patients in controlled ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation
Time Frame: 21 days
incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Chirurgical Marie Lannelongue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2019

Primary Completion (Anticipated)

January 3, 2021

Study Completion (Anticipated)

January 3, 2021

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-A02418-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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