NCT05276921

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

February 28, 2022

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ultrasound mesure of thickness of quadriceps and abdominal muscles

    at inclusive

Study Arms (1)

Patient

Postoperative ICU patient

Other: ultrasound

Interventions

Quadriceps and abdominal muscle ultrasonography

Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

postoperative ICU patient

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

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

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 14, 2022

Study Start

December 20, 2019

Primary Completion

May 28, 2020

Study Completion

June 26, 2020

Last Updated

March 14, 2022

Record last verified: 2022-02

Locations