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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Group | Sham Comparator | 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); |
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| Transcutaneous diaphragm electrical stimulation group | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham electrical stimulation | Device | A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medrinal | Le Havre | 76600 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37649092 | Derived | Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Transcutaneous diaphragm electrical stimulation | Device | A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes |
|
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 |