Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients
- Conditions
- Intensive Care UnitMechanical VentilationCritical Illness
- Registration Number
- NCT04171024
- Lead Sponsor
- Groupe Hospitalier du Havre
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Patients intubated and ventilated for at least 24 h
- Patients who were expected to have at least 48h after inclusion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Diaphragm Thickening fraction Once, At the start of the spontaneous breathing trial 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.
- Secondary Outcome Measures
Name Time Method Diaphragm atrophy Once a day under mechanical ventilation, throughout the study Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning
Inspiratory strength Once, At the start of the spontaneous breathing trial Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve
Cough strength Once, At the start of the spontaneous breathing trial Peak expiratory cough flow is measured with the ventilator
Proportion of patients successfully liberated from the ventilator After 3 days of spontaneous breathing Extubation failure is reported when a patient present a respiratory distress and need an tracheal intubation in the 48 hours past extubation
Related Research Topics
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Trial Locations
- Locations (1)
Medrinal
🇫🇷Le Havre, France
Medrinal🇫🇷Le Havre, France