Skip to main content
OpenTrials
Completed

NCT Number: NCT04171024

Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Intensive Care Unit Mechanical Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medrinal

Le Havre, 76600, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham electrical stimulation

Device

A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes

Transcutaneous diaphragm electrical stimulation

Device

A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

Primary outcomes

  1. 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

  1. Diaphragm atrophy

    Time frame: Once a day under mechanical ventilation, throughout the study

    Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning

  2. Inspiratory strength

    Time frame: Once, At the start of the spontaneous breathing trial

    Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve

  3. Cough strength

    Time frame: Once, At the start of the spontaneous breathing trial

    Peak expiratory cough flow is measured with the ventilator

  4. Proportion of patients successfully liberated from the ventilator

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study title

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

Acronym: TESLA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2019
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.