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New treatment option for ARDS (Moderate or Severe)
Official title STimulation to Activate RespIration
ClinicalTrials.gov ID: NCT06832306
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Have arterial hypoxemia defined by one of:
- PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or
You likely can't join if
- Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema...
- 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.
- Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles.
- BMI \>70 kg/m2.
See the full eligibility criteria
- 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
- 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...
- Are receiving pulmonary vasodilators for acute hypoxemia, or
- Are being ventilated in the prone position for acute hypoxemia, and
- Have been mechanically ventilated for AHRF in the ICU for \<96 hours at the time of enrolment, and
- Are expected to require invasive mechanical ventilation ≥48 hours after enrollment in the opinion of the treating clinician
- 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.
- Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles.
- BMI \>70 kg/m2.
- 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...
- Patient expected to transition to fully palliative care within 72 hours of enrollment.
- Chronic severe liver disease (e.g., Child-Pugh Score ≥10)
- Treating clinician deems enrollment not clinically appropriate.
- Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study.
- 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.
- Known or suspected to be pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Shreveport, Louisiana, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Columbia, South Carolina, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Shreveport, Louisiana, United States; Winston-Salem, North Carolina, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Columbia, South Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.