An interventional study of PEPNS System in Ventilator Induced Diaphragmatic Dysfunction (VIDD), sponsored by Stimdia Medical Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Stimdia Medical Inc. · Not applicable, Interventional, and Treatment
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).
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.
Stimdia Medical Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: PEPNS System
PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated.
Also known as: pdSTIM
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.
Time frame: 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%.
Time frame: Up to 48 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 48 hours
| Milestone | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| percentage of phernic nerve capture | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Percent Capture of Left and/or Right Phrenic Nerve | 96.56 |
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%.
| percentage of stimulated breaths | PEPNS System |
|---|---|
| Percent of Breaths Within Work of Breathing Range | 96.77 (96.58 to 96.95) |
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.
| percentage of patients | PEPNS System |
|---|---|
| Safe and Successful Lead Placement | 100 |
Phrenic nerve stimulation in synchrony with Mechanical Ventilation breaths will be measured to verify that is occurs with inspiration.
| percentage of patients | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Phrenic Nerve Stimulation Effectiveness | 100 |
The percentage of patients who experience one or more serious device/procedure-related adverse events during the study will be reported.
| percentage of patients | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Serious Device/Procedure Related Adverse Events | 0 |
Collected over Adverse event data was collected during the therapy period (48 hours) and additional 30-37 days until follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy | 4/12 (33.3%) | 4/12 (33.3%) | 0/12 (0%) |
| Event | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Patient DeathNervous system disorders | 4/12 |
| Age, Continuous(years) | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Mean | 61.9 ± 7.5 |
| Sex: Female, Male(Participants) | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Female | 1 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| White | 12 |
| BMI(kg/m^2) | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Mean | 29.1 ± 6.6 |
| Neck Circumference at the Cricoid Cartilage(centimeter) | Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy |
|---|---|
| Mean | 44.6 ± 5.3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stimdia Medical Inc.