Ventilator-Induced Diaphragm DysfunctionERASNCT05404477
Study of TransAeris® System for Enhanced Recovery After Surgery in France
A study testing TransAeris System in people with Ventilator-Induced Diaphragm Dysfunction, run by Synapse Biomedical at 1 site in France.
Trial summary
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator-Induced Diaphragm Dysfunction
- What is being tested?
- TransAeris System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2022to 17 Aug 2023
- Phase
- Interventional
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is undergoing an open cardiac procedure by median sternotomy
- Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:
- Prior open cardiac surgery
- Left Ventricular Ejection Fraction (LVEF) ≤ 30%
- History of TIA or CVA
- Pre-operative or anticipated intraoperative intra-aortic balloon pump
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- History of COPD
- Subject is at least 22 years of age
- Informed consent has been obtained from the subject
- Subject is covered by a healthcare insurance
Who cannot join
- Subject is on invasive mechanical ventilation prior to procedure
- Subject has known or pre-existing phrenic nerve paralysis
- Subject is having a left ventricular assist device (LVAD) implanted
- Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
- Subject is pregnant or lactating
- Subject is actively participating in another clinical study which could affect outcomes in this study
- Subject deprived of liberty
- Subject under court protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients in France at Risk of Prolonged Mechanical Ventilation
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).
Read the detailed description
This study is a monocentric and open label randomized study in adult open cardiac surgery patients. Eligible patients from whom informed consent is obtained are enrolled in the study. All subjects will be implanted with the TransLoc electrodes during their primary surgery. Patients are randomized to treatment or control groups prior to surgical placement of the TransLoc electrodes.
Comparison will be made between treatment and control patients during the initial 120 hours of study, then comparison of cross-over control patients' EMG from baseline to treatment.
Further comparison of MV Time, ventilator free days and other outcome measures will be made for all patients, over the course of the 30-day treatment period, to literature on an observational basis.
- Conditions
- Ventilator-Induced Diaphragm Dysfunction
- Being tested
- TransAeris System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransAeris SystemDevice
The TransAeris System includes four TransLoc® intramuscular diaphragm electrodes, the TransAeris external stimulator, and the FrictionLoc® connectors which provide the interface between the TransLoc electrodes and the TransAeris stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Treatment with TransAeris stimulation upon completion of procedure Receives: Device: TransAeris System |
| Control | Other | Control subject will cross-over to treatment with the TransAeris System if still on mechanical ventilation at 120 hours post-op Receives: Device: TransAeris System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious device-related adverse events
Number of serious device-related adverse effects
Measured: 60 days after implantation
Time on mechanical ventilation
Time measured in hours on Mechanical Ventilation and Proportion of patients weaned at 48- and 120-hours post-op
Measured: 90 days after study completion
Secondary outcomes (7)
ICU Care
Number of instances of interference with ICU care
Measured: 90 days after study completion
Device related adverse events
Number of Device related adverse events
Measured: 90 days after study completion
Mortality
Mortality at 30-day post removal of electrodes
Measured: 90 days after study completion
Mechanical ventilation time
Time on mechanical ventilation measured in hours from entry to the ICU and reversed paralytics
Measured: 90 days after study completion
EMG
EMG analysis of cross-over patients
Measured: 90 days after study completion
Ventilator Free Days
Number of days alive and free from mechanical ventilation
Measured: 90 days after study completion
Length of stay
Number of days in the ICU and in the hospital
Measured: 90 days after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start22 Jun 2022
- Primary completion13 Jul 2023
- Study completion17 Aug 2023
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 Ventilator-Induced Diaphragm DysfunctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synapse Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles-Henri David, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404477
- Sponsor's protocol ID
- CLIN 20-1000-108
- Acronym
- ERAS
- Status last verified
- Nov 2024
- First submitted
- 13 May 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
David CH, Vourc'h M, Guimbretiere G, Mugniot A, Lacoste P, Cadiet J, Rozec B, Arora R, Pelletier M, Sabik J, Onders R. Multicentre Study of Diaphragm Pacing in High-Risk Cardiac Surgery to Decrease Postoperative Mechanical Ventilation. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf472. doi: 10.1093/ejcts/ezaf472.
PubMed 41416899
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients in France at Risk of Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05404477
- Acronym / sponsor ID
- ERAS / CLIN 20-1000-108
- Conditions
- Ventilator-Induced Diaphragm Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Synapse BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 3 Jun 2022 (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 will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).
Detailed description
This study is a monocentric and open label randomized study in adult open cardiac surgery patients. Eligible patients from whom informed consent is obtained are enrolled in the study. All subjects will be implanted with the TransLoc electrodes during their primary surgery. Patients are randomized to treatment or control groups prior to surgical placement of the TransLoc electrodes.
Comparison will be made between treatment and control patients during the initial 120 hours of study, then comparison of cross-over control patients' EMG from baseline to treatment.
Further comparison of MV Time, ventilator free days and other outcome measures will be made for all patients, over the course of the 30-day treatment period, to literature on an observational basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: TransAeris SystemTreatment with TransAeris stimulation upon completion of procedure |
| Control | Other | Device: TransAeris SystemControl subject will cross-over to treatment with the TransAeris System if still on mechanical ventilation at 120 hours post-op |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is undergoing an open cardiac procedure by median sternotomy
- Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:
- Subject is at least 22 years of age
- Informed consent has been obtained from the subject
- Subject is covered by a healthcare insurance
Key exclusion criteria (8 listed)
- Subject is on invasive mechanical ventilation prior to procedure
- Subject has known or pre-existing phrenic nerve paralysis
- Subject is having a left ventricular assist device (LVAD) implanted
- Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
- Subject is pregnant or lactating
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 |
|---|---|---|
| TransAeris SystemThe TransAeris System includes four TransLoc® intramuscular diaphragm electrodes, the TransAeris external stimulator, and the FrictionLoc® connectors which provide the interface between the TransLoc electrodes and the TransAeris stimulator. | Device | Control, Treatment |
Primary outcome
Serious device-related adverse events
Time frame: 60 days after implantation
Number of serious device-related adverse effects
Time on mechanical ventilation
Time frame: 90 days after study completion
Time measured in hours on Mechanical Ventilation and Proportion of patients weaned at 48- and 120-hours post-op
7 secondary outcomes
ICU Care
Time frame: 90 days after study completion
Device related adverse events
Time frame: 90 days after study completion
Mortality
Time frame: 90 days after study completion
Mechanical ventilation time
Time frame: 90 days after study completion
EMG
Time frame: 90 days after study completion
Ventilator Free Days
Time frame: 90 days after study completion
Length of stay
Time frame: 90 days after study completion
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 12 Nov 2024.
- Derived from this study: PubMed 41416899David CH, Vourc'h M, Guimbretiere G, Mugniot A, Lacoste P, Cadiet J, Rozec B, Arora R, Pelletier M, Sabik J, Onders R. Multicentre Study of Diaphragm Pacing in High-Risk Cardiac Surgery to Decrease Postoperative Mechanical Ventilation. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf472. doi: 10.1093/ejcts/ezaf472.
- Individual participant dataSharing planned: No
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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.
Charles-Henri David principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransAeris System in people with Ventilator-Induced Diaphragm Dysfunction, run by Synapse Biomedical 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 10 inclusion and 8 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 12 Nov 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Serious device-related adverse events (time frame: 60 days after implantation). The study lists 2 primary outcomes in all. 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 NCT05404477, 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 12 Nov 2024.