Assessment of the Prognostic Value of the Thickness of the Quadriceps and Abdominal Muscles Measured by Ultrasound for 28-day Mortality in Postoperative ICU Patients (SARCOPENIE)

March 9, 2022 updated by: Centre Hospitalier Universitaire Dijon

Ultrasound measurement of muscle thickness, particularly of the quadriceps, can be used to highlight a reduction in lean mass. Sarcopenia is annvoluntary loss of lean mass, and it is a frequent and major problem in the intensive care unit (ICU). Sarcopenia is associated with significant morbidity and mortality, as previously demonstrated by CT scan measurements.

Nevertheless, due to its nature and cost, it does not appears reasonable to perform CT sarcopenia evaluation in all ICU patients. Described in the literature as evolving rapidly upon admission to ICU, accurate assessment of this loss of muscle mass would allow early detection of sarcopenia and adaptation of therapeutic management, particularly nutritional and rehabilitative.

There are many advantages to evaluating sarcopenia by ultrasound measurement: simple, rapid, achievable at the patient's bedside, no exposure to radiation, non-invasive, and low cost. The abdominal muscles (external oblique, internal oblique, transverse) constitute the accessory respiratory muscles. Easily accessible by ultrasound, they are a potential target for the evaluation of sarcopenia, which could be responsible for ventilatory withdrawal failures, prolonged stays in intensive care and associated complications. The combined ultrasound measurement of the quadriceps and accessory respiratory muscles in ICU patients therefore appears to be an innovative approach. Considering the ease of implementation, the validity of ultrasound (confirmed in the literature), and the safety of the technique, we wish to evaluate the link between the muscle mass at arrival in the postoperative Intensive Care Unit of the Dijon University Hospital by ultrasound measurement of the quadriceps and accessory respiratory muscles, and: mortality, duration of mechanical ventilation, length of stay and occurrence of intercurrent events.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dijon, France
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

postoperative ICU patient

Description

Inclusion Criteria:

  • Person who has not opposed (or non-opposition of health care proxy for patients who are comatose or under the influence of sedative drugs) after receiving information about the study
  • All adult patients admitted to the postoperative intensive care unit.

Exclusion Criteria:

  • Protected adult or minor
  • Pregnant or breastfeeding woman
  • Lower limb amputation
  • Refusal to participate of the patient or health care proxy
  • Patient with pre-existing neuromuscular condition, tetra or paraplegia
  • Morbid obesity as defined by BMI ≥ 40
  • BPCO stage ≥ 3; heart failure with LVEF < 50%; patients with symptomatic valvulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
Postoperative ICU patient
Quadriceps and abdominal muscle ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ultrasound mesure of thickness of quadriceps and abdominal muscles
Time Frame: at inclusive
at inclusive

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2019

Primary Completion (Actual)

May 28, 2020

Study Completion (Actual)

June 26, 2020

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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