STimulation to Activate RespIration

Launched by LUNGPACER MEDICAL INC. · Feb 14, 2025

Keywords

ClinConnect Summary

The STimulation to Activate RespIration trial is a study designed to explore a new method to help patients who are on mechanical ventilation due to serious breathing problems, specifically those with conditions like Acute Respiratory Distress Syndrome (ARDS). The trial will compare two groups: one group will receive a special treatment called diaphragm neurostimulation-assisted ventilation (DNAV) along with standard lung-protective ventilation, while the other group will receive only standard lung-protective ventilation. The goal is to see if the new treatment helps patients breathe better and recover more effectively.

To be eligible for the trial, participants need to be at least 18 years old and have recently developed significant breathing issues requiring ventilation. They must be in the ICU and have been on mechanical ventilation for less than 72 hours, with a doctor expecting them to need this support for at least 48 more hours. However, there are several conditions that may prevent someone from participating, such as having certain chronic lung diseases or severe health problems that could complicate recovery. If eligible, participants will be randomly assigned to one of the two treatment groups and will be monitored closely throughout the study. It's important to know that the trial is not yet recruiting participants, so those interested will need to wait for it to start.

Gender

ALL

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.