Health TrialsbyHealthPanel

STimulation to Activate RespIration

ConditionsARDS (Moderate or Severe)AHRFMechanically Ventilated ICU Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLungpacer Medical Inc.

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18 years or older, and

Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and

Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and

PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or

Disqualifiers

Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism.

Underlying chronic parenchymal lung disease that may make recovery/extubation a challenge (e.g., COPD, pulmonary fibrosis).

Broncho-pleural fistula at the time of eligibility assessment.

Require extracorporeal membrane oxygenation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

Stimulation delivered on >50% of ventilator-triggered breaths (ascertained from continuous recordings stored in the Console)

Time frame
30 days
3

Rehabilitation sessions delivered at least once per day on >50% of days when the patient was breathing in assisted (patient-triggered) mechanical ventilation

Time frame
30 days

Secondary outcomes

1

Unanticipated serious adverse device events (USADE) and incidence of device- or procedure-related SAEs in the Treatment group

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lungpacer Medical Inc.

Lead sponsor

Source ClinicalTrials.gov
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