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Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

Phase 4
Completed
Conditions
Intensive Care Unit
Mechanical Ventilation
Critical 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Diaphragm Thickening fractionOnce, 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
NameTimeMethod
Diaphragm atrophyOnce a day under mechanical ventilation, throughout the study

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

Inspiratory strengthOnce, At the start of the spontaneous breathing trial

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

Cough strengthOnce, At the start of the spontaneous breathing trial

Peak expiratory cough flow is measured with the ventilator

Proportion of patients successfully liberated from the ventilatorAfter 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

Trial Locations

Locations (1)

Medrinal

🇫🇷

Le Havre, France

Medrinal
🇫🇷Le Havre, France

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