Clinical trial NCT03550222: Muscle Evaluation Using Ultrasound in the Critically Ill
Official title: Muscle Evaluation Using Ultrasound in the Critically Ill : ULTRAMUSCLE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
ICU Acquired Weakness
Keywords: Diaphragmatic dysfunction
Mechanical Ventilation
ICU acquired weakness
Weaning
Skeletal muscles
Respiratory muscles
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Ultrasound characteristics of the quadriceps
timeFrame: 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
Secondary outcomes:
Other outcomes:
measure: Ultrasound characteristics of the biceps
timeFrame: 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
measure: Ultrasound characteristics of the diaphragm
timeFrame: 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
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: BORIS JUNG, MD, PhD
role: STUDY_CHAIR
References:
citation: Aarab Y, Flatres A, Garnier F, Capdevila M, Raynaud F, Lacampagne A, Chapeau D, Klouche K, Etienne P, Jaber S, Molinari N, Gamon L, Matecki S, Jung B. Shear Wave Elastography, a New Tool for Diaphragmatic Qualitative Assessment: A Translational Study. Am J Respir Crit Care Med. 2021 Oct 1;204(7):797-806. doi: 10.1164/rccm.202011-4086OC.
citation: Flatres A, Aarab Y, Nougaret S, Garnier F, Larcher R, Amalric M, Klouche K, Etienne P, Subra G, Jaber S, Molinari N, Matecki S, Jung B. Real-time shear wave ultrasound elastography: a new tool for the evaluation of diaphragm and limb muscle stiffness in critically ill patients. Crit Care. 2020 Feb 3;24(1):34. doi: 10.1186/s13054-020-2745-6.