Ventilator Induced Diaphragmatic Dysfunction (VIDD)NCT03559933
PEPNS System Feasibility Study
A study testing PEPNS System in people with Ventilator Induced Diaphragmatic Dysfunction (VIDD), run by Stimdia Medical Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Induced Diaphragmatic Dysfunction (VIDD)
- What is being tested?
- PEPNS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jul 2018to 29 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years or older (Adult).
- Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
- Subject who in the opinion of the admitting consultant/intensivist is likely to be ventilated for > 48 hours from time of recruitment since study treatment will be for up to 48 hours.
Who cannot join
- Subject has a left ventricular ejection fraction (LVEF) < 20%.
- Subject unlikely to survive 72 hours due to coexisting medical conditions.
- Subject has an implanted pulse generator or implanted electronic device:
- Subject has experienced an Acute Myocardial Infarction (AMI) within 72 hours prior to this screening or patient is on high dose inotropic support or subject is deemed to be in cardiogenic shock.
- Subject has significant bleeding diathesis, or is at risk of significant haemorrhage, patient is receiving full dose systemic anticoagulation
- Subject has a known or suspected phrenic nerve paralysis or neuromuscular or inflammatory muscle diseases where the diaphragm itself may not be functional.
Show all 18Show fewer
- Subject has an active systemic infection or local infection at or around the insertion site. Subject is neutropenic or has signs of significant immunocompromise.
- Subject is known or suspected to be pregnant or is lactating.
- Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol.
- Subject is currently enrolled or is expected to be enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
- Subject has undergone a surgery or interventional procedure within the neck region aside from placement of an internal jugular (IJ) vein catheter.
- Subject has been diagnosed and has been treated for neck cancer within the past 5 years.
- Subject is known to have a demonstrated intra cardiac thrombus on echocardiography.
- Subject has uncontrolled hyperthyroidism, hypertension.
- Subject has had any cerebral ischemic event (Stroke or Transient Ischemic Attack TIA) in the 6-month interval preceding the screening date.
- Subject has degenerative nerve disorders such as amyotrophic laterals sclerosis (ALS).
- Subject has an elevated hemidiaphragm on chest x-ray.
- Subject written informed consent not obtained.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) System Feasibility Study
The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).
Read the detailed description
Mechanical ventilation is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory mechanical ventilation and sedation the diaphragm begins to atrophy within as little as 18 hours. The PEPNS System consists of a console and disposable lead and will be used to stimulate the patient's diaphragm to contract in synchrony with the inspiratory cycle of the ventilator. The proprietary phrenic nerve to diaphragm stimulation (pdSTIM) Lead incorporates multipolar electrodes that align with the left and right phrenic nerves in order to stimulate the nerves to the diaphragm. This feasibility trial will investigate the safety and performance of the PEPNS System as a therapy by stimulating the diaphragm over a 48 hour period to facilitate weaning from the mechanical ventilator. The patient population includes those need to be mechanically ventilated for at least 48 hours and up to 7 days in the ICU.
- Being tested
- PEPNS System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPNS SystemDevice
Also called pdSTIM
PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated.
| Study group | Role | What they receive |
|---|---|---|
| PEPNS System | Experimental | The pdSTIM lead will be temporarily inserted near the right and left phrenic nerves and connected to the PEPNS system console in order to stimulate the phrenic nerves and activate the diaphragm on the patients until extubated/removed from mechanical ventilation or until 48 hours has elapsed, whichever comes first. Receives: Device: PEPNS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Capture of Left and/or Right Phrenic Nerve
Capture of the Left and/or Right Phrenic Nerve > 80% with an output parameter of < 10.5 volts. Capture was defined as diaphragmatic movement as a direct consequence of electrical phrenic nerve stimulation. Capture for this analysis was defined as synchrony of the stimulated breath with the output parameter <10.5 volts and Work of Breath between 0.2 and 2.0 Joules/L. Synchrony was achieved if the lag time between start of inspiration and start of stimulation was less than 88 ms. The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects, and the outcome of capture was yes/no based on whether the stimulation captures the diaphragm with multiple observations per subject.
Measured: Up to 48 hours
Percent of Breaths Within Work of Breathing Range
Work of Breathing (WOB) kept between 0.2 and 2.0 joules/L for 80% of stimulated breaths. Outcome is measured as a percentage of stimulated breaths that had a WOB between 0.2 joules/L and 2 joules/L and the performance goal was 80%.
Measured: Up to 48 hours
Secondary outcomes (3)
Safe and Successful Lead Placement
The percentage of patients who receive safe and successful placement of the multipolar lead in the left and right phrenic nerve utilizing ultrasound guidance will be determined.
Measured: Up to 48 hours
Phrenic Nerve Stimulation Effectiveness
Phrenic nerve stimulation in synchrony with Mechanical Ventilation breaths will be measured to verify that is occurs with inspiration.
Measured: Up to 48 hours
Serious Device/Procedure Related Adverse Events
The percentage of patients who experience one or more serious device/procedure-related adverse events during the study will be reported.
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start10 Jul 2018
- Primary completion29 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator Induced Diaphragmatic Dysfunction (VIDD)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The pdSTIM Leads are temporarily inserted near the right and left phrenic nerves and connected to the PEPNS System console. Duration of stimulation in PEPNS study is up to 48 hours to allow periodic electrical stimulation in daily sessions until the patients is weaned or 48 hours since initiation of stimulation session has elapsed.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stimdia Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michal M Soták, MD, Principal investigator, Military University Hospital (UVN) PragueJames O'Rourke, PhD, Principal investigator, Beaumont Hospital Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559933
- Sponsor's protocol ID
- CIP0001
- Status last verified
- Jul 2021
- First submitted
- 8 Jun 2018
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There will be no patient identifying information on any of the study case reports forms and all patients will only be identified by a study number.
Publications
O'Rourke J, Sotak M, Curley GF, Doolan A, Henlin T, Mullins G, Tyll T, Omlie W, Ranieri MV. Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation. Crit Care Med. 2020 May;48(5):e362-e370. doi: 10.1097/CCM.0000000000004256.
PubMed 32191413Sotak M, Roubik K, Henlin T, Tyll T. Phrenic nerve stimulation prevents diaphragm atrophy in patients with respiratory failure on mechanical ventilation. BMC Pulm Med. 2021 Oct 8;21(1):314. doi: 10.1186/s12890-021-01677-2.
PubMed 34625059
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) System Feasibility Study
- ClinicalTrials.gov ID
- NCT03559933
- Acronym / sponsor ID
- CIP0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stimdia Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).
Detailed description
Mechanical ventilation is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory mechanical ventilation and sedation the diaphragm begins to atrophy within as little as 18 hours. The PEPNS System consists of a console and disposable lead and will be used to stimulate the patient's diaphragm to contract in synchrony with the inspiratory cycle of the ventilator. The proprietary phrenic nerve to diaphragm stimulation (pdSTIM) Lead incorporates multipolar electrodes that align with the left and right phrenic nerves in order to stimulate the nerves to the diaphragm. This feasibility trial will investigate the safety and performance of the PEPNS System as a therapy by stimulating the diaphragm over a 48 hour period to facilitate weaning from the mechanical ventilator. The patient population includes those need to be mechanically ventilated for at least 48 hours and up to 7 days in the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The pdSTIM Leads are temporarily inserted near the right and left phrenic nerves and connected to the PEPNS System console. Duration of stimulation in PEPNS study is up to 48 hours to allow periodic electrical stimulation in daily sessions until the patients is weaned or 48 hours since initiation of stimulation session has elapsed.
| Arm | Type | Receives |
|---|---|---|
| PEPNS System | Experimental | Device: PEPNS SystemThe pdSTIM lead will be temporarily inserted near the right and left phrenic nerves and connected to the PEPNS system console in order to stimulate the phrenic nerves and activate the diaphragm on the patients until extubated/removed from mechanical ventilation or until 48 hours has elapsed, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older (Adult).
- Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
- Subject who in the opinion of the admitting consultant/intensivist is likely to be ventilated for > 48 hours from time of recruitment since study treatment will be for up to 48 hours.
Key exclusion criteria (18 listed)
- Subject has a left ventricular ejection fraction (LVEF) < 20%.
- Subject unlikely to survive 72 hours due to coexisting medical conditions.
- Subject has an implanted pulse generator or implanted electronic device:
- Subject has experienced an Acute Myocardial Infarction (AMI) within 72 hours prior to this screening or patient is on high dose inotropic support or subject is deemed to be in cardiogenic shock.
- Subject has significant bleeding diathesis, or is at risk of significant haemorrhage, patient is receiving full dose systemic anticoagulation
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 |
|---|---|---|
| PEPNS SystemAlso: pdSTIMPEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated. | Device | PEPNS System |
Primary outcome
Percent Capture of Left and/or Right Phrenic Nerve
Time frame: Up to 48 hours
Capture of the Left and/or Right Phrenic Nerve > 80% with an output parameter of < 10.5 volts. Capture was defined as diaphragmatic movement as a direct consequence of electrical phrenic nerve stimulation. Capture for this analysis was defined as synchrony of the stimulated breath with the output parameter <10.5 volts and Work of Breath between 0.2 and 2.0 Joules/L. Synchrony was achieved if the lag time between start of inspiration and start of stimulation was less than 88 ms. The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects, and the outcome of capture was yes/no based on whether the stimulation captures the diaphragm with multiple observations per subject.
Percent of Breaths Within Work of Breathing Range
Time frame: Up to 48 hours
Work of Breathing (WOB) kept between 0.2 and 2.0 joules/L for 80% of stimulated breaths. Outcome is measured as a percentage of stimulated breaths that had a WOB between 0.2 joules/L and 2 joules/L and the performance goal was 80%.
3 secondary outcomes
Safe and Successful Lead Placement
Time frame: Up to 48 hours
Phrenic Nerve Stimulation Effectiveness
Time frame: Up to 48 hours
Serious Device/Procedure Related Adverse Events
Time frame: Up to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32191413O'Rourke J, Sotak M, Curley GF, Doolan A, Henlin T, Mullins G, Tyll T, Omlie W, Ranieri MV. Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation. Crit Care Med. 2020 May;48(5):e362-e370. doi: 10.1097/CCM.0000000000004256.
- Derived from this study: PubMed 34625059Sotak M, Roubik K, Henlin T, Tyll T. Phrenic nerve stimulation prevents diaphragm atrophy in patients with respiratory failure on mechanical ventilation. BMC Pulm Med. 2021 Oct 8;21(1):314. doi: 10.1186/s12890-021-01677-2.
- Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical VentilationLink provided by the sponsor.
- Individual participant dataSharing planned: No. There will be no patient identifying information on any of the study case reports forms and all patients will only be identified by a study number.
Related trials for Ventilator Induced Diaphragmatic Dysfunction (VIDD)
Recruiting
Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Ventilator-induced Diaphragm Dysfunction, VIDD
Not yet recruiting
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
Ventilator Induced Diaphragm Dysfunction
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.
Michal M Soták, MD principal investigator
Military University Hospital (UVN) Prague
James O'Rourke, PhD principal investigator
Beaumont Hospital Dublin, Ireland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEPNS System in people with Ventilator Induced Diaphragmatic Dysfunction (VIDD), run by Stimdia Medical Inc. at 2 sites in 2 countries.
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 3 inclusion and 18 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Ireland. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Capture of Left and/or Right Phrenic Nerve (time frame: Up to 48 hours). 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 NCT03559933, which also lists 2 linked publications.
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 16 Sep 2021.