Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

Groupe Hospitalier du Havre66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Critical Illness Mechanical Ventilation Intensive Care Unit

Interventions

Sham electrical stimulationDEVICE

A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes

Transcutaneous diaphragm electrical stimulationDEVICE

A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Medrinal

Le Havre, France

Outcomes

Primary Outcomes

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.

Time frame: Once, At the start of the spontaneous breathing trial

Secondary Outcomes

Diaphragm atrophy

Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning

Time frame: Once a day under mechanical ventilation, throughout the study

Inspiratory strength

Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve

Time frame: Once, At the start of the spontaneous breathing trial

Cough strength

Peak expiratory cough flow is measured with the ventilator

Time frame: 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

Time frame: After 3 days of spontaneous breathing

Data from ClinicalTrials.gov

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