Cardiac Surgery With Extracorporeal CirculationMUSCANCT05412095
Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients
An observational study of Cardiac Surgery With Extracorporeal Circulation and Thoracic Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cardiac and thoracic surgery are major procedures. In order to estimate the operative risk, many scores have been developed, including the Euroscore 2 in cardiac surgery. However, the Euroscore has limitations since it does not assess all the parameters that may influence postoperative complications, such as the… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery With Extracorporeal Circulation, Thoracic Surgery
- What is being tested?
- Ultrasound of the abdominal wall muscles, Ultrasound quadricipital and Ultrasound of the diaphragm
- How many people
- 301 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to 26 Sep 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patient requiring cardiac or thoracic surgery
Who may be able to join
- Patient 65 years or older
- Patients who have not objected to their inclusion in the study
- Any patient requiring elective cardiac surgery, with extracorporeal circulation extracorporeal circulation OR
- Any patient requiring lung surgery with resection of at least one lobe
Who cannot join
- pneumectomy
- Person who is not affiliated to national health insurance
- Person subject to a measure of legal protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding women
- Major unable to express consent
- Persons with amputations of the proximal segment of a lower limb
- Persons suffering from a pre-existing neuromuscular pathology, tetra or paraplegia
- Person who must undergo emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients: a Prospective Observational Study
Cardiac and thoracic surgery are major procedures. In order to estimate the operative risk, many scores have been developed, including the Euroscore 2 in cardiac surgery. However, the Euroscore has limitations since it does not assess all the parameters that may influence postoperative complications, such as the patient's general condition or the status of his or her functional reserves.
However, it has been shown that the preoperative functional reserves have a significant impact on the patient's risk of developing postoperative complications following major surgery. In addition, there is a strong association between cardiac failure and a well-described decrease in peripheral muscle lean mass (sarcopenia) in patients older than 65 years.
Read more
Usually, a nutritional assessment is performed during the pre-anesthesia consultation. This assessment is based on clinical and biological criteria that are not totally predictive of the patient's functional reserve status.
Lean body mass (muscle) is a well-validated marker for the assessment of patients' functional reserves. However, the techniques used to date are complex and require radiation.
This study aims to use ultrasound of muscle groups (respiratory muscles - Quadriceps muscle - Diaphragm) to study the relationship between preoperative muscle mass and postoperative complications in patients over 65 years of age undergoing cardiac or thoracic surgery.
This is a prospective observational study to be conducted at the Dijon University Hospital by the cardiovascular anesthesia-intensive care department. A total of 300 patients will participate in this study, and we have planned to complete the project over a 2-year period. The participating patients (if they do not present any exclusion criteria and are not opposed to inclusion) will be included and undergo a muscle ultrasound in the cardiovascular surgery department or the thoracic and pulmonary surgery department the day before their intervention.
- Being tested
- Ultrasound of the abdominal wall muscles, Ultrasound quadricipital, Ultrasound of the diaphragm, Ultrasound of the inter-costal muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the abdominal wall musclesOther
the measurements will be performed during inspiration and expiration to take into account variability during the respiratory cycle. The examination is performed bilaterally and comparatively and lasts between 3 and 5 minutes.
Ultrasound quadricipitalOther
The examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.
Ultrasound of the diaphragmOther
The examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.
Ultrasound of the inter-costal musclesOther
measurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation
Ultrasound of the inter-costal musclesOther
In spontaneous ventilation, lying down, arms by the side of the body, palms up, head down
| Study group | Role | What they receive |
|---|---|---|
| Cardiology patient | Patient requiring cardiac surgery with bypass Receives: Other: Ultrasound of the abdominal wall muscles; Other: Ultrasound quadricipital; Other: Ultrasound of the diaphragm; Other: Ultrasound of the inter-costal muscles | |
| Pneumology patient | Patient requiring lung surgery with resection of at least one lobe Receives: Other: Ultrasound of the abdominal wall muscles; Other: Ultrasound quadricipital; Other: Ultrasound of the diaphragm; Other: Ultrasound of the inter-costal muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of acute renal failure
Measured: Within 30 days after surgery
Occurrence of a respiratory complication
Occurrence of acute respiratory failure in cardiac surgery and occurrence of a severe extra-respiratory complication according to the european perioperative clinical outcome definition in pulmonary surgery
Measured: Within 30 days after surgery
Occurrence of a cardiovascular complication
Measured: Within 30 days after surgery
Occurrence of an infectious complication
Measured: Within 30 days after surgery
Death
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start31 May 2022
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery With Extracorporeal CirculationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412095
- Sponsor's protocol ID
- BERTHOUD 2021
- Acronym
- MUSCA
- Status last verified
- Jan 2026
- First submitted
- 7 Jun 2022
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berthoud V, Nguyen M, Vinay J, Perrot J, Pages PB, Guinot PG, Bouhemad B. Increase in Diaphragm and Expiratory respiratory muscles thickness is not associated with postoperative pulmonary complications after thoracic surgery: A prospective ultrasound cohort study. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101683. doi: 10.1016/j.accpm.2025.101683. Epub 2025 Nov 12.
PubMed 41238178
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05412095
- Acronym / sponsor ID
- MUSCA / BERTHOUD 2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 9 Jun 2022 (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.
Cardiac and thoracic surgery are major procedures. In order to estimate the operative risk, many scores have been developed, including the Euroscore 2 in cardiac surgery. However, the Euroscore has limitations since it does not assess all the parameters that may influence postoperative complications, such as the patient's general condition or the status of his or her functional reserves.
However, it has been shown that the preoperative functional reserves have a significant impact on the patient's risk of developing postoperative complications following major surgery. In addition, there is a strong association between cardiac failure and a well-described decrease in peripheral muscle lean mass (sarcopenia) in patients older than 65 years.
Usually, a nutritional assessment is performed during the pre-anesthesia consultation. This assessment is based on clinical and biological criteria that are not totally predictive of the patient's functional reserve status.
Lean body mass (muscle) is a well-validated marker for the assessment of patients' functional reserves. However, the techniques used to date are complex and require radiation.
This study aims to use ultrasound of muscle groups (respiratory muscles - Quadriceps muscle - Diaphragm) to study the relationship between preoperative muscle mass and postoperative complications in patients over 65 years of age undergoing cardiac or thoracic surgery.
This is a prospective observational study to be conducted at the Dijon University Hospital by the cardiovascular anesthesia-intensive care department. A total of 300 patients will participate in this study, and we have planned to complete the project over a 2-year period. The participating patients (if they do not present any exclusion criteria and are not opposed to inclusion) will be included and undergo a muscle ultrasound in the cardiovascular surgery department or the thoracic and pulmonary surgery department the day before their intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiology patient | – | Other: Ultrasound of the abdominal wall muscles, Other: Ultrasound quadricipital, Other: Ultrasound of the diaphragm, Other: Ultrasound of the inter-costal musclesPatient requiring cardiac surgery with bypass |
| Pneumology patient | – | Other: Ultrasound of the abdominal wall muscles, Other: Ultrasound quadricipital, Other: Ultrasound of the diaphragm, Other: Ultrasound of the inter-costal musclesPatient requiring lung surgery with resection of at least one lobe |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patient requiring cardiac or thoracic surgery
Key inclusion criteria (4 listed)
- Patient 65 years or older
- Patients who have not objected to their inclusion in the study
- Any patient requiring elective cardiac surgery, with extracorporeal circulation extracorporeal circulation OR
- Any patient requiring lung surgery with resection of at least one lobe
Key exclusion criteria (8 listed)
- pneumectomy
- Person who is not affiliated to national health insurance
- Person subject to a measure of legal protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding women
- Major unable to express consent
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 of the abdominal wall musclesthe measurements will be performed during inspiration and expiration to take into account variability during the respiratory cycle. The examination is performed bilaterally and comparatively and lasts between 3 and 5 minutes. | Other | Cardiology patient, Pneumology patient |
| Ultrasound quadricipitalThe examination is performed bilaterally and comparatively and takes between 3 and 5 minutes. | Other | Cardiology patient, Pneumology patient |
| Ultrasound of the diaphragmThe examination is performed bilaterally and comparatively and takes between 5 and 10 minutes. | Other | Cardiology patient, Pneumology patient |
| Ultrasound of the inter-costal musclesmeasurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation | Other | Cardiology patient, Pneumology patient |
| Ultrasound of the inter-costal musclesIn spontaneous ventilation, lying down, arms by the side of the body, palms up, head down | Other | Cardiology patient, Pneumology patient |
Primary outcome
Onset of acute renal failure
Time frame: Within 30 days after surgery
Occurrence of a respiratory complication
Time frame: Within 30 days after surgery
Occurrence of acute respiratory failure in cardiac surgery and occurrence of a severe extra-respiratory complication according to the european perioperative clinical outcome definition in pulmonary surgery
Occurrence of a cardiovascular complication
Time frame: Within 30 days after surgery
Occurrence of an infectious complication
Time frame: Within 30 days after surgery
Death
Time frame: Within 30 days after surgery
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 29 Jan 2026.
- Results publication: PubMed 41238178Berthoud V, Nguyen M, Vinay J, Perrot J, Pages PB, Guinot PG, Bouhemad B. Increase in Diaphragm and Expiratory respiratory muscles thickness is not associated with postoperative pulmonary complications after thoracic surgery: A prospective ultrasound cohort study. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101683. doi: 10.1016/j.accpm.2025.101683. Epub 2025 Nov 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Surgery With Extracorporeal Circulation and Thoracic Surgery, run by Centre Hospitalier Universitaire Dijon 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 8 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 29 Jan 2026. 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?
Onset of acute renal failure (time frame: Within 30 days after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05412095, which also lists 1 linked publication.
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 29 Jan 2026.