STimulation to Activate RespIration

Conditions

• AHRF
• ARDS (Moderate or Severe)
• Mechanically Ventilated ICU Patients

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Phrenic Nerve Stimulation — DEVICE
  During controlled MV when patients are not breathing, continuous diaphragm neurostimulation-assisted ventilation (DNAV) will be delivered in synchrony with each ventilator-delivered breath.

Study Details

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 ventilation (Treatment) vs. lung-protective ventilation alone (Control).

Key Dates

Start date

May 28, 2025

Status verified

May 2025

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  Treatment group subjects will have the Catheter placed percutaneously into the left jugular vein or left subclavian vein. Mapping will identify the electrodes that stimulate the phrenic nerves and enable diaphragm contraction using the AeroNova Console. The stimulation level will be titrated to target a level of diaphragm activation equivalent to resting quiet breathing by adjusting the stimulation frequency and amplitude. Subjects will receive continuous stimulation plus standard of care lung-protective ventilation.
• No Intervention: Control
  Standard of Care - Lung-protective ventilation

Primary Outcome Measure

Successful device insertion, mapping, and initiation of stimulation within 18 hours of meeting readiness-to-stimulate criteria [ Time Frame: Within 18 hours of meeting readiness to stimulate criteria ]

Central Contacts

• Megan O'Toole
  (484) 350-4530
  [email protected]
• STARI Study
  (484) 350-4530
  [email protected]

Locations (5)

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