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Clinical Trials/NCT05412095
NCT05412095
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country301 target enrollmentMay 31, 2022

Overview

Phase
Not Applicable
Intervention
Ultrasound of the abdominal wall muscles
Conditions
Cardiac Surgery With Extracorporeal Circulation
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
301
Locations
1
Primary Endpoint
Occurrence of a cardiovascular complication
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 31, 2022
End Date
September 26, 2023
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Cardiology patient

Patient requiring cardiac surgery with bypass

Intervention: Ultrasound of the abdominal wall muscles

Cardiology patient

Patient requiring cardiac surgery with bypass

Intervention: Ultrasound quadricipital

Cardiology patient

Patient requiring cardiac surgery with bypass

Intervention: Ultrasound of the diaphragm

Cardiology patient

Patient requiring cardiac surgery with bypass

Intervention: Ultrasound of the inter-costal muscles

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

Intervention: Ultrasound of the abdominal wall muscles

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

Intervention: Ultrasound quadricipital

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

Intervention: Ultrasound of the diaphragm

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

Intervention: Ultrasound of the inter-costal muscles

Outcomes

Primary Outcomes

Occurrence of a cardiovascular complication

Time Frame: Within 30 days after surgery

Death

Time Frame: Within 30 days after surgery

Onset of acute renal failure

Time Frame: Within 30 days after surgery

Occurrence of an infectious complication

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

Study Sites (1)

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