Clinical Trials Directory

Trials / Completed

CompletedNCT05412095

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
301 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERUltrasound of the abdominal wall musclesthe 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.
OTHERUltrasound quadricipitalThe examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.
OTHERUltrasound of the diaphragmThe examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.
OTHERUltrasound of the inter-costal musclesmeasurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation
OTHERUltrasound of the inter-costal musclesIn spontaneous ventilation, lying down, arms by the side of the body, palms up, head down

Timeline

Start date
2022-05-31
Primary completion
2023-09-26
Completion
2023-09-26
First posted
2022-06-09
Last updated
2026-01-29

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05412095. Inclusion in this directory is not an endorsement.