Muscle Evaluation Using Ultrasound in the Critically Ill

Completed

• Conditions: ICU Acquired Weakness; Critical Illness

• Registration Number: NCT03550222
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2017-09-26
• Study Start: 2018-01-30
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-08
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound characteristics of the quadriceps	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)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France