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

ICU Acquired Weakness Clinical Trial

— DETECT  

Official title:

Diagnostic Accuracy of Early ulTrasound Measurement of Quadriceps Thickness During Neuromuscular EleCTrical Stimulation for the Diagnosis of ICU-acquired Weakness : an Observational Study (DETECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722445
• Other study ID #: 2020-A01690-39
• Status: Completed
• Start date: August 16, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Groupe Hospitalier du Havre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mechanical ventilation for at least 24 hours

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthenia
• ICU Acquired Weakness
• Muscular Atrophy
• Quadriceps Muscle Atrophy

Intervention

Diagnostic Test:
• Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES)
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.

Locations

Country	Name	City	State
France	Groupe Hospitalier du Havre	Montivilliers

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory muscles strength	Maximal Inspiratory Pressure and Maximal Expiratory Pressure	In the 30 minutes before extubation (during spontaneous breathing trial)
Secondary	Cough capacity	Peak Cough Flow	In the 30 minutes before extubation (during spontaneous breathing trial)
Secondary	Extubation failure/success	Reintubation or death	Within 48 hours after extubation