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

NCT05412095 | Completed

• 1 other identifier: BERTHOUD 2021
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery With Extracorporeal Circulation; Thoracic Surgery

Outcome Measures

Primary Outcomes (5)

• Onset of acute renal failure

  Within 30 days after surgery

• 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

• Occurrence of a cardiovascular complication

  Within 30 days after surgery

• Occurrence of an infectious complication

  Within 30 days after surgery

• Death

  Within 30 days after surgery

Study Arms (2)

Cardiology patient

Patient requiring cardiac surgery with bypass

Other: Ultrasound of the abdominal wall muscles; Other: Ultrasound quadricipital; Other: Ultrasound of the diaphragm; Other: Ultrasound of the inter-costal muscles

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

Other: Ultrasound of the abdominal wall muscles; Other: Ultrasound quadricipital; Other: Ultrasound of the diaphragm; Other: Ultrasound of the inter-costal muscles

Interventions

Ultrasound of the abdominal wall muscles OTHER

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.

Cardiology patient; Pneumology patient

Ultrasound quadricipital OTHER

The examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.

Cardiology patient; Pneumology patient

Ultrasound of the diaphragm OTHER

The examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.

Cardiology patient; Pneumology patient

Ultrasound of the inter-costal muscles OTHER

measurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation

Cardiology patient; Pneumology patient

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient requiring cardiac or thoracic surgery

You may qualify if:

• Patient 65 years or older
• Any patient requiring elective cardiac surgery, with extracorporeal circulation extracorporeal circulation OR
• Any patient requiring lung surgery with resection of at least one lobe

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

• Berthoud V, Nguyen M, Vinay J, Perrot J, Pages PB, Guinot PG, Bouhemad B. Increase in Diaphragm and Expiratory respiratory muscles thickness is not associated with postoperative pulmonary complications after thoracic surgery: A prospective ultrasound cohort study. Anaesth Crit Care Pain Med. 2025 Nov 12;45(4):101683. doi: 10.1016/j.accpm.2025.101683. Online ahead of print.

  PMID: 41238178 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: May 31, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

FR (1)