Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

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

Patrocinadores

Patrocinador principal: Groupe Hospitalier du Havre

Fuente Groupe Hospitalier du Havre
Resumen breve

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.

Estado general Recruiting
Fecha de inicio December 10, 2019
Fecha de Terminación January 7, 2022
Fecha de finalización primaria January 1, 2022
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Diaphragm Thickening fraction Once, At the start of the spontaneous breathing trial
Resultado secundario
Medida Periodo de tiempo
Diaphragm atrophy Once a day under mechanical ventilation, throughout the study
Inspiratory strength Once, At the start of the spontaneous breathing trial
Cough strength Once, At the start of the spontaneous breathing trial
Proportion of patients successfully liberated from the ventilator After 3 days of spontaneous breathing
Inscripción 66
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Sham electrical stimulation

Descripción: A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes

Etiqueta de grupo de brazo: Sham Group

Tipo de intervención: Device

Nombre de intervención: Transcutaneous diaphragm electrical stimulation

Descripción: A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

Etiqueta de grupo de brazo: Transcutaneous diaphragm electrical stimulation group

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 85 Years

Voluntarios Saludables: No

Contacto general

Apellido: Clement Medrinal, PhD

Teléfono: +33630039745

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Investigador: Medrinal Clement Medrinal +33630039745 [email protected] Clement Medrinal, PhD Principal Investigator Guillaume Prieur, Msc Sub-Investigator Yann Combret, Msc Sub-Investigator
Ubicacion Paises

France

Fecha de verificación

January 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Groupe Hospitalier du Havre

Nombre completo del investigador: Clément MEDRINAL

Título del investigador: Principal Investigator

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Sham Group

Tipo: Sham Comparator

Descripción: 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);

Etiqueta: Transcutaneous diaphragm electrical stimulation group

Tipo: Experimental

Descripción: 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

Acrónimo TESLA
Datos del paciente Undecided
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Prevention

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov