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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05412095
Collaborator
(none)
300
1
30.1
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ultrasound of the abdominal wall muscles
  • Other: Ultrasound quadricipital
  • Other: Ultrasound of the diaphragm
  • Other: Ultrasound of the inter-costal muscles
  • Other: Ultrasound of the inter-costal muscles

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
May 31, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Cardiology patient

Patient requiring cardiac surgery with bypass

Other: Ultrasound of the abdominal wall muscles
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.

Other: Ultrasound quadricipital
The examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.

Other: Ultrasound of the diaphragm
The examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.

Other: Ultrasound of the inter-costal muscles
measurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation

Other: Ultrasound of the inter-costal muscles
In spontaneous ventilation, lying down, arms by the side of the body, palms up, head down

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

Other: Ultrasound of the abdominal wall muscles
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.

Other: Ultrasound quadricipital
The examination is performed bilaterally and comparatively and takes between 3 and 5 minutes.

Other: Ultrasound of the diaphragm
The examination is performed bilaterally and comparatively and takes between 5 and 10 minutes.

Other: Ultrasound of the inter-costal muscles
measurements performed bilaterally on a patient in a half-sitting position at 45° and in spontaneous ventilation

Other: Ultrasound of the inter-costal muscles
In spontaneous ventilation, lying down, arms by the side of the body, palms up, head down

Outcome Measures

Primary Outcome Measures

  1. Onset of acute renal failure [Within 30 days after surgery]

  2. 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

  3. Occurrence of a cardiovascular complication [Within 30 days after surgery]

  4. Occurrence of an infectious complication [Within 30 days after surgery]

  5. Death [Within 30 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourgogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT05412095
Other Study ID Numbers:
  • BERTHOUD 2021
First Posted:
Jun 9, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022