Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Groupe Hospitalier du Havre
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Diaphragm Thickening fraction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Sham Group
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);
Intervention: Sham electrical stimulation (Device)
Transcutaneous diaphragm electrical stimulation group
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
Intervention: Transcutaneous diaphragm electrical stimulation (Device)
Outcomes
Primary Outcomes
Diaphragm Thickening fraction
Time Frame: 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 Outcomes
- 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)
Investigators
Clément MEDRINAL
Principal Investigator
Groupe Hospitalier du Havre