Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation

Recruiting

• Conditions: Sarcopenia; Lung Transplant; Physiotherapy
• Interventions: Other: ultrasound measurement of the cross-sectional area of the rectus femoris

• Registration Number: NCT06268171
• Lead Sponsor: Hopital Foch

Brief Summary

In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.

After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.

Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.

In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-20
• Study Start: 2024-03-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-09-04
• Study Completion: 2025-11-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patient over the age of 18
• Patient registered on the lung transplant list at Hôpital Foch for a single or double-lung transplant
• Patient who did not object to inclusion in the study
• Patient affiliated to a French health insurance plan

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Exclusion Criteria

• Patient listed for a combined transplant (heart-lung, liver-lung, lung-kidney)
• Patient on national priority list (super-emergency)
• Pregnant or breast-feeding patient
• Patient under guardianship

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	ultrasound measurement of the cross-sectional area of the rectus femoris	transplant patients with ultrasound measurement of the cross-sectional area of the rectus femoris

Primary Outcome Measures

Name	Time	Method
Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation	Baseline and Day 7

Secondary Outcome Measures

Name	Time	Method
Measure change in cross-sectional area of the rectus femoris at D7 according to LT pattern	Baseline and day 14
Evaluate the relationship between length of stay in intensive care unit and variation in cross-sectional area of the rectus femoris at D7	Baseline and day 7
Determine the relationship between cross-sectional area of the rectus femoris at D-1 and Body Mass Index	Baseline

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, Hauts De Seine, France