Diaphragm IssuesNCT04457427
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
A study testing NeuRx Diaphragm Pacing System (DPS) in people with Diaphragm Issues and Ventilator-Induced Lung Injury, run by Synapse Biomedical at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
- What is being tested?
- NeuRx Diaphragm Pacing System (DPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
- Signed written informed consent has been obtained prior to performing any study related procedure(s)
- Subject is at least 18 years of age
- Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)
Who cannot join
- Diaphragm malformation which makes electrode insertion impossible
- Presence of an implantable cardioverter-defibrillator
- Severe chronic obstructive pulmonary disease (COPD)
- Subject is pregnant or breastfeeding
- Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
- Terminal patients expected to die during their stay in the hospital
- Participation in other clinical studies that could interfere with the results in the ongoing study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
Read the detailed description
15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.
- Being tested
- NeuRx Diaphragm Pacing System (DPS)
- Keywords
- Mechanical Ventilators, Ventilators, Pulmonary, Failure to wean, Lung Injury, Ventilator-Induced, Tracheostomy, Diaphragm pacing
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuRx Diaphragm Pacing System (DPS)Device
4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.
| Study group | Role | What they receive |
|---|---|---|
| Tracheostomy, no DPS | No intervention | 5 patients undergoing tracheostomy for failure to wean will receive no additional intervention. |
| Trachesotomy with immediate DPS stimulation and monitoring | Experimental | 5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring. Receives: Device: NeuRx Diaphragm Pacing System (DPS) |
| Trachesotomy with DPS monitoring, stimulation on day 5 | Active comparator | 5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure. Receives: Device: NeuRx Diaphragm Pacing System (DPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and procedure safety
Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first
Measured: Through study completion, an average of 6 years
Monitoring
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
Measured: Through study completion, an average of 6 years
Stimulation
Increase in magnitude of diaphragm burst activity with stimulation
Measured: Through study completion, an average of 6 years
Secondary outcomes (1)
Effects of diaphragm stimulation
Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay
Measured: Through study completion, an average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study startDec 2016 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm IssuesStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synapse Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tunç Laçin, MD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457427
- Sponsor's protocol ID
- CLIN 20-1000-35
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04457427
- Acronym / sponsor ID
- CLIN 20-1000-35
- Keywords
- Mechanical Ventilators, Ventilators, Pulmonary, Failure to wean, Lung Injury, Ventilator-Induced, Tracheostomy, Diaphragm pacing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synapse BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 7 Jul 2020 (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 is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
Detailed description
15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tracheostomy, no DPS | No intervention | –5 patients undergoing tracheostomy for failure to wean will receive no additional intervention. |
| Trachesotomy with immediate DPS stimulation and monitoring | Experimental | Device: NeuRx Diaphragm Pacing System (DPS)5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring. |
| Trachesotomy with DPS monitoring, stimulation on day 5 | Active comparator | Device: NeuRx Diaphragm Pacing System (DPS)5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
- Signed written informed consent has been obtained prior to performing any study related procedure(s)
- Subject is at least 18 years of age
- Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)
Key exclusion criteria (7 listed)
- Diaphragm malformation which makes electrode insertion impossible
- Presence of an implantable cardioverter-defibrillator
- Severe chronic obstructive pulmonary disease (COPD)
- Subject is pregnant or breastfeeding
- Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
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 |
|---|---|---|
| NeuRx Diaphragm Pacing System (DPS)4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity. | Device | Trachesotomy with DPS monitoring, stimulation on day 5, Trachesotomy with immediate DPS stimulation and monitoring |
Primary outcome
Device and procedure safety
Time frame: Through study completion, an average of 6 years
Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first
Monitoring
Time frame: Through study completion, an average of 6 years
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
Stimulation
Time frame: Through study completion, an average of 6 years
Increase in magnitude of diaphragm burst activity with stimulation
1 secondary outcome
Effects of diaphragm stimulation
Time frame: Through study completion, an average of 6 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Click here for more information about the Sponsor.Link provided by the sponsor.
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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.
Tunç Laçin, MD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuRx Diaphragm Pacing System (DPS) in people with Diaphragm Issues and Ventilator-Induced Lung Injury, run by Synapse Biomedical at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 7 Jul 2020. 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 Turkey (Türkiye). 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 was withdrawn before enrolling participants, so there are no results.
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?
Device and procedure safety (time frame: Through study completion, an average of 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2020.