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

Recruiting

• Conditions: Thoracic Surgery; Cardiac Surgery With Extracorporeal Circulation
• Interventions: Other: Ultrasound of the abdominal wall muscles; Other: Ultrasound quadricipital; Other: Ultrasound of the diaphragm; Other: Ultrasound of the inter-costal muscles

• Registration Number: NCT05412095
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiology patient	Ultrasound of the abdominal wall muscles	Patient requiring cardiac surgery with bypass
Pneumology patient	Ultrasound of the diaphragm	Patient requiring lung surgery with resection of at least one lobe
Pneumology patient	Ultrasound of the abdominal wall muscles	Patient requiring lung surgery with resection of at least one lobe
Cardiology patient	Ultrasound quadricipital	Patient requiring cardiac surgery with bypass
Cardiology patient	Ultrasound of the diaphragm	Patient requiring cardiac surgery with bypass
Pneumology patient	Ultrasound quadricipital	Patient requiring lung surgery with resection of at least one lobe
Pneumology patient	Ultrasound of the inter-costal muscles	Patient requiring lung surgery with resection of at least one lobe
Cardiology patient	Ultrasound of the inter-costal muscles	Patient requiring cardiac surgery with bypass

Primary Outcome Measures

Name	Time	Method
Occurrence of a cardiovascular complication	Within 30 days after surgery
Death	Within 30 days after surgery
Onset of acute renal failure	Within 30 days after surgery
Occurrence of an infectious complication	Within 30 days after surgery
Occurrence of a respiratory complication	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

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France