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Recruiting NCT06832306

STimulation to Activate RespIration

No phase Interventional ARDS (Moderate or Severe) AHRF Mechanically Ventilated ICU Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phrenic Nerve Stimulation.
Who it may be relevant to
Registry conditions: ARDS (Moderate or Severe), AHRF, Mechanically Ventilated ICU Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure

Overview

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

  • Device Phrenic Nerve Stimulation
    During controlled MV when patients are not breathing, continuous diaphragm neurostimulation-assisted ventilation (DNAV) will be delivered in synchrony with each ventilator-delivered breath.

Primary outcome measures

  • 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]
  • Stimulation delivered on >50% of ventilator-triggered breaths (ascertained from continuous recordings stored in the Console) [Time frame: 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 [Time frame: 30 days]
Secondary outcome measures (1)
  • Unanticipated serious adverse device events (USADE) and incidence of device- or procedure-related SAEs in the Treatment group [Time frame: 30 days]

Eligibility criteria

Inclusion 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 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
  • 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

Exclusion criteria

  • 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 situ, poor target vessels).
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • University of California San Diego — La Jolla
  • Louisiana State University Health Sciences — Shreveport
  • Wake Forest University School of Medicine — Winston-Salem
  • Cleveland Clinic — Cleveland
  • Temple University — Philadelphia
  • Prisma Health — Columbia
Canada · 1 center
  • University Health Network (UHN) — Toronto

Identifiers

NCT: NCT06832306 · P-600 · 75A0123C00021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗