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Completed

NCT Number: NCT03550222

Muscle Evaluation Using Ultrasound in the Critically Ill

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.

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Key information

Conditions

Critical Illness Disease Attributes ICU Acquired Weakness Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Other outcomes

  1. Ultrasound characteristics of the biceps

    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 biceps : thickness of the biceps (mm)

  2. Ultrasound characteristics of the diaphragm

    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

    Ultrasound characteristics of the diaphragm : thickness (mm)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Muscle Evaluation Using Ultrasound in the Critically Ill : ULTRAMUSCLE Study

Acronym: ULTRAMUSCLE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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