CompletedNot Applicable

PEPNS System Feasibility Study

Czechia, Ireland12 participantsStarted 2018-07-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percent Capture of Left and/or Right Phrenic Nerve

Timeframe: Up to 48 hours

Percent of Breaths Within Work of Breathing Range

Timeframe: Up to 48 hours

Trial details

NCT IDNCT03559933

SponsorStimdia Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-29

Results submitted2021-05-16

View on ClinicalTrials.gov More Ventilator Induced Diaphragmatic Dysfunction (VIDD) trials