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NCT Number: NCT04722445

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

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.

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Key information

Conditions

ICU Acquired Weakness Quadriceps Muscle Atrophy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier du Havre

Montivilliers, 76290, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. ICU-Aw diagnosis

    Time frame: In the 24 hours following extubation

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

Secondary outcomes

  1. Respiratory muscles strength

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

    Maximal Inspiratory Pressure and Maximal Expiratory Pressure

  2. Cough capacity

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

    Peak Cough Flow

  3. Extubation failure/success

    Time frame: Within 48 hours after extubation

    Reintubation or death

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study 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)

Acronym: DETECT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2021
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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