Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients (TESLA)

Groupe Hospitalier du Havre

Status and phase: Completed; Phase 4

Conditions: Critical Illness; Intensive Care Unit; Mechanical Ventilation

Treatments: Device: Sham electrical stimulation; Device: Transcutaneous diaphragm electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04171024

2019-A00782-55

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups

Sham Group

Sham Comparator group

Description:

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);

Treatment:

Device: Sham electrical stimulation

Transcutaneous diaphragm electrical stimulation group

Experimental group

Description:

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

Treatment:

Device: Transcutaneous diaphragm electrical stimulation