Ultrasound Measurement of Quadriceps Shortening During Neuromuscular Electrical Stimulation in Critically Ill Patients

NCT04722445 | Completed

• 1 other identifier: 2020-A01690-39
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

ICU-Aw is highly prevalent (50%) among critically ill patients. Its diagnosis is usually delayed as it requires patients' awakening and collaboration to provide accurate measurement. This study aims to investigate the accuracy of an early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation to diagnose future ICU-Aw in critically ill patients.

Conditions

ICU Acquired Weakness; Quadriceps Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• ICU-Aw diagnosis

  Measured with the Medical Research Council score (scored 0 (minimum) to 60 (maximum); with a score \< 48 meaning ICU-acquired weakness)

  In the 24 hours following extubation

Secondary Outcomes (3)

• Respiratory muscles strength

  In the 30 minutes before extubation (during spontaneous breathing trial)

• Cough capacity

  In the 30 minutes before extubation (during spontaneous breathing trial)

• Extubation failure/success

  Within 48 hours after extubation

Interventions

Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES) DIAGNOSTIC_TEST

NMES will be applied to the quadriceps muscle to generate muscle contraction. Ultrasound measurement of the quadriceps thickness will be provided during contraction and rest, and the shortening of the quadriceps muscle will be measured. A second measurement using Shear-wave elastography measurement will also be undertaken. The measures will be undertaken at day 1 of neuromuscular blockers liberation (if any) as well as at day 3 and day 7 for the patients that will still be received mechanical ventilation at that time.

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 admitted in ICU departement and mechanically ventilated for at least 24 hours without counterindications to provide NMES.

You may qualify if:

• Mechanical ventilation for at least 24 hours

You may not qualify if:

• Decision to withhold life-sustaining treatment
• Pregnancy
• Degenerative neurological pathology with disabling muscle weakness
• Pace Maker
• Inability to communicate
• Chronic loss of autonomy described by the patient's family
• Guardianship

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (1)

Groupe Hospitalier du Havre

Montivilliers, 76290, France

Location

Related Publications (1)

• Medrinal C, Combret Y, Hilfiker R, Prieur G, Aroichane N, Gravier FE, Bonnevie T, Contal O, Lamia B. ICU outcomes can be predicted by noninvasive muscle evaluation: a meta-analysis. Eur Respir J. 2020 Oct 1;56(4):1902482. doi: 10.1183/13993003.02482-2019. Print 2020 Oct.

  PMID: 32366493 BACKGROUND

Study Officials

• Yann Combret, PhD, PT

  Groupe Hospitalier du Havre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: January 25, 2021
• Study Start: August 16, 2021
• Primary Completion: October 16, 2023
• Study Completion: December 30, 2023
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after publication and ending 60 months following article publication.
• Access Criteria: For individual participant data meta-analysis. Proposals should be directed to yann.combret@gmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

FR (1)