Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients

Thoracic Surgery Clinical Trial

— MUSCA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412095
• Other study ID #: BERTHOUD 2021
• Status: Recruiting
• Start date: May 31, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Vivien BERTHOUD
• Phone: 0380293528
• Email: vivien.berthoud[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Cardiac Surgery With Extracorporeal Circulation
• Thoracic Surgery

Intervention

Other:
• Ultrasound of the abdominal wall muscles
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 quadricipital
The examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.
• Ultrasound of the diaphragm
The examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.
• Ultrasound of the inter-costal muscles
measurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation
• Ultrasound of the inter-costal muscles
In spontaneous ventilation, lying down, arms by the side of the body, palms up, head down

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of acute renal failure		Within 30 days after surgery
Primary	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	Within 30 days after surgery
Primary	Occurrence of a cardiovascular complication		Within 30 days after surgery
Primary	Occurrence of an infectious complication		Within 30 days after surgery
Primary	Death		Within 30 days after surgery