Critical IllnessPhase 4TESLANCT04171024
Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients
A Phase 4 study testing Transcutaneous diaphragm electrical stimulation in people with Critical Illness and Mechanical Ventilation, run by Groupe Hospitalier du Havre at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness, Mechanical Ventilation, Intensive Care Unit
- What is being tested?
- Transcutaneous diaphragm electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2019to 3 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients intubated and ventilated for at least 24 h
- Patients who were expected to have at least 48h after inclusion
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Sham electrical stimulation, Transcutaneous diaphragm electrical stimulation
- Keywords
- Diaphragm dysfunction, Transcutaneous Electrical Stimulation, Intensive care unit, Mechanical ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham electrical stimulationDevice
A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes
Transcutaneous diaphragm electrical stimulationDevice
A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes
| Study group | Role | What they receive |
|---|---|---|
| Sham Group | Sham comparator | 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); Receives: Device: Sham electrical stimulation |
| Transcutaneous diaphragm electrical stimulation group | Experimental | 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 Receives: Device: Transcutaneous diaphragm electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once, At the start of the spontaneous breathing trial
Secondary outcomes (4)
Diaphragm atrophy
Diaphragm thickeness is measured each day of the study until mechanical ventilation weaning
Measured: Once a day under mechanical ventilation, throughout the study
Inspiratory strength
Maximal inspiratory pressure is measured via an electrical manometer with unidirectional valve
Measured: Once, At the start of the spontaneous breathing trial
Cough strength
Peak expiratory cough flow is measured with the ventilator
Measured: 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
Measured: After 3 days of spontaneous breathing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start10 Dec 2019
- Primary completion2 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clément MEDRINAL, Groupe Hospitalier du Havre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171024
- Sponsor's protocol ID
- 2019-A00782-55
- Acronym
- TESLA
- Status last verified
- Aug 2022
- First submitted
- 8 Nov 2019
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1.
PubMed 37649092
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction
- ClinicalTrials.gov ID
- NCT04171024
- Acronym / sponsor ID
- TESLA / 2019-A00782-55
- Keywords
- Diaphragm dysfunction, Transcutaneous Electrical Stimulation, Intensive care unit, Mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Group | Sham comparator | Device: Sham electrical stimulationTwo 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); |
| Transcutaneous diaphragm electrical stimulation group | Experimental | Device: Transcutaneous diaphragm electrical stimulationTwo 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients intubated and ventilated for at least 24 h
- Patients who were expected to have at least 48h after inclusion
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham electrical stimulationA non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes | Device | Sham Group |
| Transcutaneous diaphragm electrical stimulationA non invasive diaphragm electrical stimulation using transcutaneous thoracic probes | Device | Transcutaneous diaphragm electrical stimulation group |
Primary outcome
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.
4 secondary outcomes
Diaphragm atrophy
Time frame: Once a day under mechanical ventilation, throughout the study
Inspiratory strength
Time frame: Once, At the start of the spontaneous breathing trial
Cough strength
Time frame: Once, At the start of the spontaneous breathing trial
Proportion of patients successfully liberated from the ventilator
Time frame: After 3 days of spontaneous breathing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 37649092Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transcutaneous diaphragm electrical stimulation in people with Critical Illness and Mechanical Ventilation, run by Groupe Hospitalier du Havre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Thickening fraction (time frame: Once, At the start of the spontaneous breathing trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.