Ventilator Induced Diaphragm DysfunctionERASNCT04899856
Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
A study testing TransAeris in people with Ventilator Induced Diaphragm Dysfunction, run by Synapse Biomedical at 1 site in United States.
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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to May 2024
- 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
Show all 9Show fewer
- History of COPD
- Subject is at least 22 years of age
- Informed consent has been obtained from the patient
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 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients 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 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.
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Being tested
- TransAeris
- Keywords
- VIDD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransAerisDevice
TransAeris is used to provide neuromuscular electrical stimulation to the diaphragm while the patient is on mechanical ventilation to prevent, slow, or reverse diaphragm disuse atrophy and, more generally, to prevent and treat VIDD.
| Study group | Role | What they receive |
|---|---|---|
| Control / Crossover to TransAeris Therapy | Other | The "Control" group will be treated per standard hospital policy following electrode implant. If the participant is not liberated from mechanical ventilation after 120 hours (5 days), the participant will begin using TransAeris therapy. The participant will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery. Receives: Device: TransAeris |
| Treatment with TransAeris Therapy | Experimental | The "Treatment" group will start TranAeris therapy shortly after arrival in the Intensive Care Unit (ICU). Participants will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery. Receives: Device: TransAeris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing serious device-related adverse effects
All participants will be assessed for serious device-related adverse effects
Measured: 60 days after implantation
Proportion of subjects weaned at 48 hours and 120 hours
Time on mechanical ventilation will be compared between the Control and Treatment groups
Measured: 90 days after study completion
Secondary outcomes (3)
Number of subjects experiencing device-related adverse events
All participants will be assessed for device-related adverse events
Measured: 90 days after study completion
Average number of days in the Intensive Care Unit (ICU)
Time in the ICU will be tracked for all study participants and averaged
Measured: 90 days after study completion
Average number of days in the hospital
Time in the hospital will be tracked for all study participants and averaged
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 posted25 May 2021
- Study start10 Aug 2021
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synapse Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond P Onders, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899856
- Sponsor's protocol ID
- 20-1000-105
- Acronym
- ERAS
- Status last verified
- Aug 2023
- First submitted
- 19 May 2021
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 18 Aug 2023. 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 at Risk of Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04899856
- Acronym / sponsor ID
- ERAS / 20-1000-105
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Keywords
- VIDD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Synapse BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 25 May 2021 (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 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.
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 |
|---|---|---|
| Control / Crossover to TransAeris Therapy | Other | Device: TransAerisThe "Control" group will be treated per standard hospital policy following electrode implant. If the participant is not liberated from mechanical ventilation after 120 hours (5 days), the participant will begin using TransAeris therapy. The participant will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery. |
| Treatment with TransAeris Therapy | Experimental | Device: TransAerisThe "Treatment" group will start TranAeris therapy shortly after arrival in the Intensive Care Unit (ICU). Participants will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 patient
Key exclusion criteria (6 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 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 |
|---|---|---|
| TransAerisTransAeris is used to provide neuromuscular electrical stimulation to the diaphragm while the patient is on mechanical ventilation to prevent, slow, or reverse diaphragm disuse atrophy and, more generally, to prevent and treat VIDD. | Device | Control / Crossover to TransAeris Therapy, Treatment with TransAeris Therapy |
Primary outcome
Number of subjects experiencing serious device-related adverse effects
Time frame: 60 days after implantation
All participants will be assessed for serious device-related adverse effects
Proportion of subjects weaned at 48 hours and 120 hours
Time frame: 90 days after study completion
Time on mechanical ventilation will be compared between the Control and Treatment groups
3 secondary outcomes
Number of subjects experiencing device-related adverse events
Time frame: 90 days after study completion
Average number of days in the Intensive Care Unit (ICU)
Time frame: 90 days after study completion
Average number of days in the hospital
Time frame: 90 days after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- 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.
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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.
Raymond P Onders, MD principal investigator
University Hospitals Cleveland Medical Center
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 in people with Ventilator Induced Diaphragm Dysfunction, run by Synapse Biomedical at 1 site in United States.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. 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 United States. 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?
Results are not available in the source record.
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?
Number of subjects experiencing serious device-related adverse effects (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 NCT04899856, 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 18 Aug 2023.