Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation (EchoSS-TP)

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Physiotherapy; Lung Transplant
• Intervention / Treatment: Other: ultrasound measurement of the cross-sectional area of the rectus femoris

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• France
  • Hauts de seine
    • Suresnes, Hauts de seine, France, 92151
      • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Lung transplant patients at Hôpital Foch

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; transplant patients with ultrasound measurement of the cross-sectional area of the rectus femoris	Other: ultrasound measurement of the cross-sectional area of the rectus femoris; ultrasound measurement of the cross-sectional area of the rectus femoris at D-1 and D+3, +7 , +14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Matthieu Reffienna, Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: 2023_0214; 2023-A02390-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No