Clinical trial NCT05412095: Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery With Extracorporeal Circulation
Thoracic Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient requiring cardiac or thoracic surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: Onset of acute renal failure
timeFrame: Within 30 days after surgery
measure: Occurrence of a respiratory complication
timeFrame: Within 30 days after surgery
measure: Occurrence of a cardiovascular complication
timeFrame: Within 30 days after surgery
measure: Occurrence of an infectious complication
timeFrame: Within 30 days after surgery
measure: Death
timeFrame: Within 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: