Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

Study Overview
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Brief Summary
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This study evaluates the effect of a transcutaneous electrical stimulation in critically ill patients compared to a sham electrical stimulation to decrease the incidence of diaphragm dysfunction before mechanical ventilation weaning.

Official Title
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Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction

Conditions
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Critical Illness, Mechanical Ventilation, Intensive Care Unit

Intervention / Treatment
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* Device: Sham electrical stimulation
* Device: Transcutaneous diaphragm electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients intubated and ventilated for at least 24 h Patients who were expected to have at least 48h after inclusion Exclusion Criteria: Patient with pacemaker Patient under neuro muscular blocker Patient post thoracic or abdominal surgery Patient with BMI more than 35 kg/m² Patient with degenerative neurological pathology Patient with cutaneous lesion may be interfered with probes Patient with chronic loss of autonomy Patient hospitalized more than 72 hours before ICU admission Patient with severe chronic obstructive pulmonary disease (FEV1 < 30%) Patient with decision to withhold life-sustaining treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Group<br>Two channels with two electrodes each were placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two channels with two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space. Transcutaneous electrical stimulation settings: Frequency (2 hertz); wave length (300 µs); | Device: Sham electrical stimulation<br>* A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes<br>|
| Experimental: Transcutaneous diaphragm electrical stimulation group<br>Two channels with two electrodes each were placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two channels with two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space. Transcutaneous electrical stimulation settings: Frequency (35 hertz); wave length (300 µs); Intensity to achieve a visual contraction | Device: Transcutaneous diaphragm electrical stimulation<br>* A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm Thickening fraction | Diaphragm ultrasound was conducted using a 4-12-MHz linear array transducer. Diaphragm thickness was measured at end-expiration (Tdi,ee) and end inspiration (Tdi,ei), and thickening fraction (TFdi) was calculated offline as (Tdi,ei-Tdi,ee)/Tdi,ee. | Once, At the start of the spontaneous breathing trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm atrophy | Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning | Once a day under mechanical ventilation, throughout the study | 
| Inspiratory strength | Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve | Once, At the start of the spontaneous breathing trial | 
| Cough strength | Peak expiratory cough flow is measured with the ventilator | Once, At the start of the spontaneous breathing trial | 
| Proportion of patients successfully liberated from the ventilator | Extubation failure is reported when a patient present a respiratory distress and need an tracheal intubation in the 48 hours past extubation | After 3 days of spontaneous breathing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragm dysfunction, Transcutaneous Electrical Stimulation, Intensive care unit, Mechanical ventilation