Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

Phase 4

Completed

• Conditions: Intensive Care Unit; Mechanical Ventilation; Critical Illness
• Interventions: Device: Sham electrical stimulation; Device: Transcutaneous diaphragm electrical stimulation

• 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

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-20
• Study Start: 2019-12-10
• Status Verified: 2022-08
• Primary Completion: 2022-08-02
• Study Completion: 2022-08-03
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

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

Arm && Interventions

Group	Intervention	Description
Sham Group	Sham electrical stimulation	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);
Transcutaneous diaphragm electrical stimulation group	Transcutaneous diaphragm electrical stimulation	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

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

Trial Locations

Locations (1)

Medrinal; 🇫🇷 Le Havre, France