- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05412095
Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients (MUSCA)
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.
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 Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dijon, France, 21000
- Chu Dijon Bourgogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Cardiology patient
Patient requiring cardiac surgery with bypass
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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.
The examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.
The examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.
measurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation
In spontaneous ventilation, lying down, arms by the side of the body, palms up, head down
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|
Pneumology patient
Patient requiring lung surgery with resection of at least one lobe
|
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.
The examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.
The examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.
measurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation
In spontaneous ventilation, lying down, arms by the side of the body, palms up, head down
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Onset of acute renal failure
Time Frame: Within 30 days after surgery
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Within 30 days after surgery
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Occurrence of a respiratory complication
Time Frame: Within 30 days after surgery
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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
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Within 30 days after surgery
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Occurrence of a cardiovascular complication
Time Frame: Within 30 days after surgery
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Within 30 days after surgery
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Occurrence of an infectious complication
Time Frame: Within 30 days after surgery
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Within 30 days after surgery
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Death
Time Frame: Within 30 days after surgery
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Within 30 days after surgery
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BERTHOUD 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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