STimulation to Activate RespIration

Recruiting N/A Interventional Study
ARDS (Moderate or Severe) AHRF Mechanically Ventilated ICU Patients
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Lungpacer Medical Inc. · Industry
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About This Trial
Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute respiratory distress syndrome (ARDS)) will be randomized 2:1 to diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System plus lung-protective ventil…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female, 18 years or older, and 2. Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and 3. Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before…
Contacts

Megan Cotts

(612) 986-7172

mcotts@lungpacer.com

CONTACT

STARI Study

(484) 350-4530

STARIstudy@lungpacer.com

CONTACT