Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

Critical Illness Clinical Trial

— TESLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171024
• Other study ID #: 2019-A00782-55
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2019
• Est. completion date: August 3, 2022

Study information

• Verified date: August 2022
• Source: Groupe Hospitalier du Havre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 3, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit
• Mechanical Ventilation

Intervention

Device:
• Sham electrical stimulation
A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes
• Transcutaneous diaphragm electrical stimulation
A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

Locations

Country	Name	City	State
France	Medrinal	Le Havre

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diaphragm atrophy	Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning	Once a day under mechanical ventilation, throughout the study
Secondary	Inspiratory strength	Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve	Once, At the start of the spontaneous breathing trial
Secondary	Cough strength	Peak expiratory cough flow is measured with the ventilator	Once, At the start of the spontaneous breathing trial
Secondary	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