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Muscle Evaluation Using Ultrasound in the Critically Ill (ULTRAMUSCLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550222
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Critical Illness ICU Acquired Weakness

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Muscle Evaluation Using Ultrasound in the Critically Ill : ULTRAMUSCLE Study
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients with at least one organ failure and an estimated duration of ICU stay of 3 days or more
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550222


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Chair: BORIS JUNG, MD, PhD University Hospital, Montpellier

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03550222    
Other Study ID Numbers: RECHMPL17_0302
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Diaphragmatic dysfunction
Mechanical Ventilation
ICU acquired weakness
Weaning
Skeletal muscles
Respiratory muscles
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes