Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients (TESLA)

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

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 Overview

• Status: Completed
• Conditions: Critical Illness; Intensive Care Unit; Mechanical Ventilation
• Intervention / Treatment: Device: Sham electrical stimulation; Device: Transcutaneous diaphragm electrical stimulation

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Le Havre, France, 76600
    • Médrinal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: 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);	Device: Sham electrical stimulation; A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes
EXPERIMENTAL: 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	Device: Transcutaneous diaphragm electrical stimulation; A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm Thickening fraction	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.	Once, At the start of the spontaneous breathing trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm atrophy	Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning	Once a day under mechanical ventilation, throughout the study
Inspiratory strength	Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve	Once, At the start of the spontaneous breathing trial
Cough strength	Peak expiratory cough flow is measured with the ventilator	Once, At the start of the spontaneous breathing trial
Proportion of patients successfully liberated from the ventilator	Extubation failure is reported when a patient present a respiratory distress and need an tracheal intubation in the 48 hours past extubation	After 3 days of spontaneous breathing

Collaborators and Investigators

• Sponsor: Groupe Hospitalier du Havre

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2019
• Primary Completion (ACTUAL): August 2, 2022
• Study Completion (ACTUAL): August 3, 2022

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Intensive care unit; Mechanical ventilation; Diaphragm dysfunction; Transcutaneous Electrical Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2019-A00782-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No