Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction

Groupe Hospitalier du Havre1 site in 1 country66 target enrollmentDecember 10, 2019

ConditionsCritical Illness Mechanical Ventilation Intensive Care Unit

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Critical Illness
Sponsor: Groupe Hospitalier du Havre
Enrollment: 66
Locations: 1
Primary Endpoint: Diaphragm Thickening fraction
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 10, 2019

End Date

August 3, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Groupe Hospitalier du Havre

Responsible Party

Principal Investigator

Clément MEDRINAL

Principal Investigator

Groupe Hospitalier du Havre

Eligibility Criteria

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

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)