STRENGTH-ICU: Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Recruiting
CT.gov ID
NCT03270163
Collaborator
Laboratoire de Physiologie de l'Exercice (Other)
72
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Study Details

Study Description

Brief Summary

Acquired Neuromyopathy of Resuscitation (NMAR) is a common condition. Its diagnosis is difficult and often late because it is based on a clinical assessment of muscle strength (MRC score) requiring the patient to be awake and cooperative.

Transcutaneous electrical stimulation consists of applying electrical stimulation along the path of a motor nerve in order to generate contraction of the previously relaxed muscle. The mechanical response thus generated is recorded and allows the muscular strength developed to be assessed. Non-invasive and easily performed in the patient's bed, transcutaneous electrical stimulation could be an interesting alternative for early assessment of muscle strength in the still sedated resuscitation patient. However, this technique could be perceived as uncomfortable or painful in the awake patient so that magnetic stimulation, which is generally much better tolerated, should be preferred. However, magnetic stimulators have a limited maximum magnetic field which may prevent supramaximal stimulation especially in patients developing generalized edema (i.e., in the initial resuscitation phase).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Transcutaneous electrical stimulation
  • Diagnostic Test: Magnetic stimulation
  • Diagnostic Test: ultrasound measurement
N/A

Detailed Description

We propose to conduct a reproducibility study of quadriceps force measurement in patients undergoing resuscitation by transcutaneous electrical and/or magnetic neurostimulation in the initial (i.e., < 96 h) and late (> 96 h) phases of resuscitation and then in the recovery phase. For each investigative technique (i.e., electrical vs. magnetic), we will perform 2 types of stimulation: single stimulation and high frequency doublet stimulation (100 Hz), repeated 3 times each.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation in Intensive Care Unit Patients
Actual Study Start Date :
Feb 10, 2021
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Magnetic and Transcutaneous electrical stimulation of quadriceps

Diagnostic Test: Transcutaneous electrical stimulation
The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening: three simple electrical stimulations, three electrical doublets at the frequency of 100Hz For each type of electrical stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.

Diagnostic Test: Magnetic stimulation
The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening: three simple magnetic stimulations, three magnetic doublets at the frequency of 100Hz For each type of magnetic stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.

Diagnostic Test: ultrasound measurement
The ultrasound measurement of the thickness of the quadriceps muscle will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening.

Outcome Measures

Primary Outcome Measures

  1. Reproductibility [At day 2]

    Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.

Secondary Outcome Measures

  1. Reproductibility [At day 4]

    Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.

  2. Reproductibility [when the patient wakes up (on average 15 days)]

    Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.

  3. Reproductibility [At day 2]

    Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.

  4. Reproductibility [At day 4]

    Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.

  5. Reproductibility [when the patient wakes up (on average 15 days)]

    Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.

  6. Reproductibility [At day 2]

    Reproductibility of the force measurement after one simple electrical muscle stimulation

  7. Reproductibility [At day 4]

    Reproductibility of the force measurement after one simple electrical muscle stimulation

  8. Reproductibility [when the patient wakes up (on average 15 days)]

    Reproductibility of the force measurement after one simple electrical muscle stimulation

  9. Reproductibility [At day 2]

    Reproductibility of the force measurement after one simple magnetic muscle stimulation

  10. Reproductibility [At day 4]

    Reproductibility of the force measurement after one simple magnetic muscle stimulation

  11. Reproductibility [At day 6]

    Reproductibility of the force measurement after one simple magnetic muscle stimulation

  12. Intensive care unit acquired muscle weakness (ICUAW) [1 month]

    Occurrence of ICUAW defined by a MRC score less than 48

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥ 18 years

  • admitted in intensive care unit B of ST-Etienne hospital

  • Predictable duration of mechanical ventilation of more than 72 hours

  • Patient whose family has given informed and written consent to the patient's participation in the study

Exclusion Criteria:
  • Pregnant woman,

  • Patients with peripheral nerve damage prior to or at the time of measurement

  • Curarized patients (non-efficacy of neurostimulation)

  • Fracture of limb or pelvis

  • Presence of a catheter in the stimulation zone (femoral artery or vein)

  • Patients suffering from psychiatric pathologies.

  • Brain pathology leading the patient to intensive care.

  • Patients with neuromuscular pathology.

  • Patients carrying equipment subject to possible electrical and/or magnetic interference,

  • Patient with spinal fracture(s) at risk of spinal cord injury

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Saint-Etienne Saint-etienne France 42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne
  • Laboratoire de Physiologie de l'Exercice

Investigators

  • Principal Investigator: Jérôme MOREL, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT03270163
Other Study ID Numbers:
  • 1708055
  • 2017-A00919-44
First Posted:
Sep 1, 2017
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021