Back to resultsTranscutaneous Diaphragm Electrical Stimulation in Critically Ill Patients (TESLA)
Primary Purpose
Critical Illness, Mechanical Ventilation, Intensive Care Unit
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Sham electrical stimulation
Transcutaneous diaphragm electrical stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness focused on measuring Diaphragm dysfunction, Transcutaneous Electrical Stimulation, Intensive care unit, Mechanical ventilation
Eligibility Criteria
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
Sites / Locations
- Medrinal
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham Group
Transcutaneous diaphragm electrical stimulation group
Arm 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);
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Diaphragm atrophy
Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning
Inspiratory strength
Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve
Cough strength
Peak expiratory cough flow is measured with the ventilator
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
Full Information
NCT ID
NCT04171024
First Posted
November 8, 2019
Last Updated
August 3, 2022
Sponsor
Groupe Hospitalier du Havre
1. Study Identification
Unique Protocol Identification Number
NCT04171024
Brief Title
Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients
Acronym
TESLA
Official Title
Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
August 2, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier du Havre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Mechanical Ventilation, Intensive Care Unit
Keywords
Diaphragm dysfunction, Transcutaneous Electrical Stimulation, Intensive care unit, Mechanical ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm 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);
Arm Title
Transcutaneous diaphragm electrical stimulation group
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Sham electrical stimulation
Intervention Description
A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes
Intervention Type
Device
Intervention Name(s)
Transcutaneous diaphragm electrical stimulation
Intervention Description
A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes
Primary Outcome Measure Information:
Title
Diaphragm Thickening fraction
Description
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.
Time Frame
Once, At the start of the spontaneous breathing trial
Secondary Outcome Measure Information:
Title
Diaphragm atrophy
Description
Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning
Time Frame
Once a day under mechanical ventilation, throughout the study
Title
Inspiratory strength
Description
Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve
Time Frame
Once, At the start of the spontaneous breathing trial
Title
Cough strength
Description
Peak expiratory cough flow is measured with the ventilator
Time Frame
Once, At the start of the spontaneous breathing trial
Title
Proportion of patients successfully liberated from the ventilator
Description
Extubation failure is reported when a patient present a respiratory distress and need an tracheal intubation in the 48 hours past extubation
Time Frame
After 3 days of spontaneous breathing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medrinal
City
Le Havre
ZIP/Postal Code
76600
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients
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