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

Sarcopenia Clinical Trial

— EchoSS-TP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06268171
• Other study ID #: 2023_0214
• Secondary ID: 2023-A02390-45
• Status: Not yet recruiting
• Start date: March 4, 2024
• Est. completion date: November 5, 2025

Study information

• Verified date: February 2024
• Source: Hopital Foch
• Contact: Elisabeth HULIER-AMMAR
• Phone: 00 33 1 46 25 11 75
• Email: e.hulier-ammar[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: November 5, 2025
• Est. primary completion date: September 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant
• Physiotherapy
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation		Baseline and Day 7
Secondary	Measure change in CSA-RF at D7 according to LT pattern		Baseline and day 14
Secondary	Evaluate the relationship between length of stay in intensive care unit and variation in CSA-RF at D7		Baseline and day 7
Secondary	Determine the relationship between CSA-RF at D-1 and Body Mass Index		Baseline