Muscle Evaluation Using Ultrasound in the Critically Ill

NCT03550222 | Completed

• 1 other identifier: RECHMPL17_0302
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; ICU Acquired Weakness

Keywords

Diaphragmatic dysfunction; Mechanical Ventilation; ICU acquired weakness; Weaning; Skeletal muscles; Respiratory muscles

Outcome Measures

Primary Outcomes (1)

• Ultrasound characteristics of the quadriceps

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

  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

Other Outcomes (2)

• Ultrasound characteristics of the biceps

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- Pregnancy, age below 18, absence of consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (2)

• 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.

  PMID: 34255974 DERIVED

• 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.

  PMID: 32014005 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• BORIS JUNG, MD, PhD

  University Hospital, Montpellier

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: June 8, 2018
• Study Start: January 30, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 30, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FR (1)