Идёт набор NCT06832306

STimulation to Activate RespIration

Без фазы С лечением ARDS (Moderate or Severe) AHRF Mechanically Ventilated ICU Patients

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Phrenic Nerve Stimulation.
Кому может быть актуально: Состояния в реестре: ARDS (Moderate or Severe), AHRF, Mechanically Ventilated ICU Patients. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Вмешательства

Устройство 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.

Первичные конечные точки

Successful device insertion, mapping, and initiation of stimulation within 18 hours of meeting readiness-to-stimulate criteria [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 30 days]

Вторичные конечные точки (1)

Unanticipated serious adverse device events (USADE) and incidence of device- or procedure-related SAEs in the Treatment group [Срок оценки: 30 days]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет