Evaluation of Diaphragmatic Function After Bi-pulmonary Transplantation

• Conditions: Lung Transplant, Diaphragmatic Function

• Registration Number: NCT03977597
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Status Verified: 2019-05
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Study First Posted: 2019-06-06
• Last Update Posted: 2019-06-06
• Primary Completion: 2021-01-03
• Study Completion: 2021-01-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation	21 days	incidence of diaphragmatic disorders (paralysis, severe and moderate dysfunction) in the post-operative period of bi-pulmonary transplantation

Trial Locations

Locations (1)

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France