N/A N=12 Treatment

PEPNS System Feasibility Study

Ventilator Induced Diaphragmatic Dysfunction (VIDD)

Bottom Line

View on ClinicalTrials.gov: NCT03559933 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Sep 2021

Primary outcome: Primary: Percent Capture of Left and/or Right Phrenic Nerve — 96.56 percentage of phernic nerve capture — p=0.0125

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PEPNS System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stimdia Medical Inc.
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Capture of Left and/or Right Phrenic Nerve	96.56	0.0125 sig
PRIMARY Percent of Breaths Within Work of Breathing Range	96.77	—
SECONDARY Safe and Successful Lead Placement	100	—
SECONDARY Phrenic Nerve Stimulation Effectiveness	100	—
SECONDARY Serious Device/Procedure Related Adverse Events	—	—

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03559933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.