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Clinical Trials/NCT03550222
NCT03550222
Completed
Not Applicable

Muscle Evaluation Using Ultrasound in the Critically Ill : ULTRAMUSCLE Study

University Hospital, Montpellier1 site in 1 country100 target enrollmentJanuary 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
University Hospital, Montpellier
Enrollment
100
Locations
1
Primary Endpoint
Ultrasound characteristics of the quadriceps
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.

Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.

The aim of the present study is to constitute an image bank and to describe the muscle mass and function recovery in critically ill patients.

Detailed Description

Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction. Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients. The aim of the present study is to constitute an image bank and to describe the mass and function recovery in critically ill patients. Ultrasound and clinical data will be collected and analysed during the ICU stay.

Registry
clinicaltrials.gov
Start Date
January 30, 2018
End Date
December 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Critically ill patients with at least one organ failure defined, organ failure being defined by a SOFA equal or above 3 for the organ, and an expected duration of ICU stay equal of above 3 days
  • Exclusion criteria:
  • Pregnancy, age below 18, absence of consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ultrasound characteristics of the quadriceps

Time Frame: Since admission at day 0 and measured repetitively by 48 hours untildischarge from ICU or date of death from any cause, whichever came first, assessed up to day 28

Changes in ultrasound characteristics of the quadriceps : cross sectional area of quadriceps (cm2)

Study Sites (1)

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