Lung TransplantEchoSS-TPNCT06268171
Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation
An observational study of Lung Transplant and Physiotherapy, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant, Physiotherapy, Sarcopenia
- What is being tested?
- ultrasound measurement of the cross-sectional area of the rectus femoris
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2024to 27 May 2025
- How long will I take part?
- 61 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant patients at Hôpital Foch
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Lung Transplant, Physiotherapy, Sarcopenia
- Being tested
- ultrasound measurement of the cross-sectional area of the rectus femoris
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound measurement of the cross-sectional area of the rectus femorisOther
ultrasound measurement of the cross-sectional area of the rectus femoris at D-1 and D+3, +7 , +14
| Study group | Role | What they receive |
|---|---|---|
| Study group | transplant patients with ultrasound measurement of the cross-sectional area of the rectus femoris Receives: Other: ultrasound measurement of the cross-sectional area of the rectus femoris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation
Measured: Baseline and Day 7
Secondary outcomes (3)
Measure change in cross-sectional area of the rectus femoris at D7 according to LT pattern
Measured: 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
Measured: Baseline and day 7
Determine the relationship between cross-sectional area of the rectus femoris at D-1 and Body Mass Index
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start27 Mar 2024
- Primary completion4 Apr 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 61 Days
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Reffienna, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268171
- Sponsor's protocol ID
- 2023_0214
- Other IDs
- 2023-A02390-45
- Acronym
- EchoSS-TP
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation
- ClinicalTrials.gov ID
- NCT06268171
- Acronym / sponsor ID
- EchoSS-TP / 2023_0214
- Conditions
- Lung Transplant, Physiotherapy, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 61 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: ultrasound measurement of the cross-sectional area of the rectus femoristransplant patients with ultrasound measurement of the cross-sectional area of the rectus femoris |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant patients at Hôpital Foch
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound measurement of the cross-sectional area of the rectus femorisultrasound measurement of the cross-sectional area of the rectus femoris at D-1 and D+3, +7 , +14 | Other | Study group |
Primary outcome
Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation
Time frame: Baseline and Day 7
3 secondary outcomes
Measure change in cross-sectional area of the rectus femoris at D7 according to LT pattern
Time frame: 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
Time frame: Baseline and day 7
Determine the relationship between cross-sectional area of the rectus femoris at D-1 and Body Mass Index
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Reffienna principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant and Physiotherapy, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation (time frame: Baseline and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.