Clinical trial NCT03559933: PEPNS System Feasibility Study
Official title: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) System Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Induced Diaphragmatic Dysfunction (VIDD)
Lead sponsor: Stimdia Medical Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older (Adult).
2. Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
3. 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.

Exclusion Criteria:

1. Subject has a left ventricular ejection fraction (LVEF) \< 20%.
2. Subject unlikely to survive 72 hours due to coexisting medical conditions.
3. Subject has an implanted pulse generator or implanted electronic device:
4. 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.
5. Subject has significant bleeding diathesis, or is at risk of significant haemorrhage, patient is receiving full dose systemic anticoagulation
6. Subject has a known or suspected phrenic nerve paralysis or neuromuscular or inflammatory muscle diseases where the diaphragm itself may not be functional.
7. Subject has an active systemic infection or local infection at or around the insertion site. Subject is neutropenic or has signs of significant immunocompromise.
8. Subject is known or suspected to be pregnant or is lactating.
9. Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol.
10. 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.
11. Subject has undergone a surgery or interventional procedure within the neck region aside from placement of an internal jugular (IJ) vein catheter.
12. Subject has been diagnosed and has been treated for neck cancer within the past 5 years.
13. Subject is known to have a demonstrated intra cardiac thrombus on echocardiography.
14. Subject has uncontrolled hyperthyroidism, hypertension.
15. Subject has had any cerebral ischemic event (Stroke or Transient Ischemic Attack TIA) in the 6-month interval preceding the screening date.
16. Subject has degenerative nerve disorders such as amyotrophic laterals sclerosis (ALS).
17. Subject has an elevated hemidiaphragm on chest x-ray.
18. Subject written informed consent not obtained.

Primary outcomes:
measure: Percent Capture of Left and/or Right Phrenic Nerve
timeFrame: Up to 48 hours
measure: Percent of Breaths Within Work of Breathing Range
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Safe and Successful Lead Placement
timeFrame: Up to 48 hours
measure: Phrenic Nerve Stimulation Effectiveness
timeFrame: Up to 48 hours
measure: Serious Device/Procedure Related Adverse Events
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Military University Hospital (ÚVN)
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Military University Hospital (UVN) Prague
name: Michal M Soták, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beaumont Hospital Dublin, Ireland
name: James O'Rourke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sotak 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.