AHRF, ARDS (Moderate or Severe), Mechanically Ventilated ICU Patients
Conditions
Brief summary
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).
Interventions
During controlled MV when patients are not breathing, continuous diaphragm neurostimulation-assisted ventilation (DNAV) will be delivered in synchrony with each ventilator-delivered breath.
Sponsors
Lungpacer Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2:1 Randomization treatment to control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 onset of need for respiratory support, and 4. Have arterial hypoxemia defined by one of: * PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or * In the absence of an available arterial blood gas, SpO2 ≤97% on FiO2 ≥0.5 and PEEP ≥5 cm H2O with reliable SpO2 trace for the 2 hours immediately preceding eligibility assessment (this correlates to an upper limit of SpO2:FiO2 ratio of 316%) or * Are receiving pulmonary vasodilators for acute hypoxemia, or * Are being ventilated in the prone position for acute hypoxemia, and 5. Have been mechanically ventilated for AHRF in the ICU for \<96 hours at the time of enrolment, and 6. Are expected to require invasive mechanical ventilation ≥48 hours after enrollment in the opinion of the treating clinician
Exclusion criteria
1. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism. 2. Underlying chronic parenchymal lung disease that may make recovery/extubation a challenge (e.g., COPD, pulmonary fibrosis). 3. Broncho-pleural fistula at the time of eligibility assessment. 4. Require extracorporeal membrane oxygenation. 5. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles. 6. BMI \>70 kg/m2. 7. Contraindications to left internal jugular vein or left subclavian vein catheterization (e.g., infection at the access site, known central venous stenosis, septic thrombophlebitis, left internal jugular ECMO cannula in situ, poor target vessels). 8. Patient expected to transition to fully palliative care within 72 hours of enrollment. 9. Chronic severe liver disease (e.g., Child-Pugh Score ≥10) 10. Treating clinician deems enrollment not clinically appropriate. 11. Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study. 12. Any electrical device (implanted or external) that may be prone to interaction with or interference from the AeroNova System, including neurological pacing/stimulator devices and cardiac pacemakers and defibrillators. 13. Known or suspected to be pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful device insertion, mapping, and initiation of stimulation within 18 hours of meeting readiness-to-stimulate criteria | Within 18 hours of meeting readiness to stimulate criteria |
| Stimulation delivered on >50% of ventilator-triggered breaths (ascertained from continuous recordings stored in the Console) | 30 days |
| Rehabilitation sessions delivered at least once per day on >50% of days when the patient was breathing in assisted (patient-triggered) mechanical ventilation | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Unanticipated serious adverse device events (USADE) and incidence of device- or procedure-related SAEs in the Treatment group | 30 days |
Countries
Canada, United States
Contacts
CONTACTMegan Cotts
CONTACTSTARI Study
PRINCIPAL_INVESTIGATOREwan Goligher, MD, PhD, FRCPC
Toronto General Hospital
Outcome results
None listed