Critical Illness, Intensive Care Unit, Mechanical Ventilation
Conditions
Keywords
Diaphragm dysfunction, Transcutaneous Electrical Stimulation, Intensive care unit, Mechanical ventilation
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.
Interventions
A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes
DEVICETranscutaneous diaphragm electrical stimulation
A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes
Sponsors
Groupe Hospitalier du Havre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed