Clinical trial NCT06832306: STimulation to Activate RespIration
Official title: A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: ARDS (Moderate or Severe)
AHRF
Mechanically Ventilated ICU Patients
Lead sponsor: Lungpacer Medical Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 Randomization treatment to control
Primary purpose: TREATMENT

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).


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 onset of need for respiratory support, and
4. Have moderate-to-severe arterial hypoxemia defined by one of:

   * PaO2:FiO2 ratio \<≤200 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 235%) or
   * Are receiving inhaled nitric oxide for acute hypoxemia, or
   * Are being ventilated in the prone position for acute hypoxemia, and
5. Have been mechanically ventilated for AHRF in the current ICU for \<72 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, and
7. Have not spontaneously triggered the ventilator for the previous 2 hours and there is no immediate plan to transition to assisted ventilation.

Exclusion Criteria:

1. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, 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. Severe hemodynamic instability (requiring norepinephrine or epinephrine \> 0.5 mcg/kg/min)
5. Require extracorporeal membrane oxygenation.
6. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles.
7. BMI \>70 kg/m2.
8. 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).
9. Patient expected to transition to fully palliative care within 72 hours of enrollment.
10. Severe liver disease (Child-Pugh Score ≥10)
11. Treating clinician deems enrollment not clinically appropriate.
12. Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study.
13. 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.
14. Known or suspected to be pregnant or lactating.

Primary outcomes:
measure: Successful device insertion, mapping, and initiation of stimulation within 18 hours of meeting readiness-to-stimulate criteria
timeFrame: Within 18 hours of meeting readiness to stimulate criteria
measure: Stimulation delivered on >50% of controlled ventilation breaths (ascertained from continuous recordings stored in the Console)
timeFrame: 30 days
measure: Rehabilitation sessions delivered at least once per day on >50% of days when the patient was in assisted ventilation for at least 12 hours
timeFrame: 30 days
Secondary outcomes:
measure: 30 days
timeFrame: 30 days
measure: Unanticipated serious adverse device events (USADE) and incidence of device- or procedure-related SAEs in the Treatment group
timeFrame: 30 days
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences
state: Louisiana
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
city: Toronto
country: Canada
facility: University Health Network (UHN)
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: Ewan Gohligher, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: