Идёт набор NCT07372794

EIT-Guided Respiratory Physiotherapy for Prolonged Mechanical Ventilation (PMV)

Без фазы С лечением Prolonged Mechanical Ventilation Respiratory Failure Critical Illness

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: EIT-Guided Respiratory Physiotherapy, Conventional Respiratory Physiotherapy.
Кому может быть актуально: Состояния в реестре: Prolonged Mechanical Ventilation, Respiratory Failure, Critical Illness. 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: Китай
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

Electrical Impedance Tomography-Guided Respiratory Physiotherapy for Liberation From Prolonged Mechanical Ventilation: A Multicenter Randomized Controlled Trial

Обзор

Patients with prolonged mechanical ventilation (PMV) frequently experience impaired ventilation distribution, respiratory muscle dysfunction, secretion retention, and delayed liberation from mechanical ventilation. Electrical impedance tomography (EIT) provides real-time bedside visualization of regional ventilation and enables individualized respiratory physiotherapy strategies. This multicenter randomized controlled trial aims to evaluate whether EIT-guided respiratory physiotherapy improves ventilator-free days at day 28 compared with conventional respiratory physiotherapy in adult patients with PMV. Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time EIT imaging is used to individualize physiotherapy strategies based on predefined ventilation distribution indicators, while the control group receives standardized physiotherapy according to institutional protocols without EIT guidance. Secondary outcomes include successful liberation from mechanical ventilation, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale, healthcare resource utilization, and safety outcomes.

Подробное описание

This multicenter randomized controlled trial evaluates the effectiveness of electrical impedance tomography (EIT)-guided respiratory physiotherapy compared with conventional respiratory physiotherapy in adult patients with prolonged mechanical ventilation (PMV).

Eligible patients receiving invasive mechanical ventilation for at least 21 consecutive days will be randomly assigned in a 1:1 ratio to either the EIT-guided group or the control group, in addition to standard ICU care.

Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. Both groups will receive standardized physiotherapy protocols with comparable treatment frequency and duration.

In the EIT-guided group, real-time EIT imaging will be used during each physiotherapy session. The control group will receive the same standardized physiotherapy components according to institutional protocols without EIT guidance.

The primary outcome is ventilator-free days at day 28 (VFD-28), defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before day 28 or remain invasively ventilated at day 28 will be assigned a value of zero. Reintubation within 72 hours will be considered treatment failure according to the predefined protocol.

Secondary outcomes include successful liberation from invasive mechanical ventilation by day 28, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale (IMS), healthcare resource utilization, and safety outcomes.

EIT-derived parameters are included as exploratory mechanistic outcomes to characterize physiological responses to the intervention and are not used for primary outcome adjudication.

Вмешательства

Другое EIT-Guided Respiratory Physiotherapy
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, individualized using real-time EIT guidance based on predefined ventilation distribution indicators. Link this intervention to: Experimental Arm
Другое Conventional Respiratory Physiotherapy
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance. Link this intervention to: Control Arm

Первичные конечные точки

Ventilator-Free Days at Day 28 (VFD-28) [Срок оценки: 28 days]

Вторичные конечные точки (8)

Successful liberation from invasive mechanical ventilation by day 28 [Срок оценки: 28 days]
Diaphragm ultrasound parameters [Срок оценки: Up to 28 days]
EIT-derived ventilation distribution indices [Срок оценки: During intervention period (up to 28 days)]
ICU Mobility Scale (IMS) change from baseline [Срок оценки: Up to ICU discharge or day 28]
ICU length of stay [Срок оценки: Up to hospital discharge]
Hospital length of stay [Срок оценки: From hospital admission to hospital discharge]
Total hospitalization cost [Срок оценки: Up to hospital discharge]
Adverse events during physiotherapy [Срок оценки: During intervention period (up to 28 days)]

Критерии участия

Критерии включения

Age ≥ 18 years.
Invasive mechanical ventilation for ≥ 21 consecutive days.
Clinically stable and eligible for respiratory physiotherapy as determined by the treating team.
Expected to remain on invasive mechanical ventilation for at least 48 hours after enrollment.
Written informed consent obtained from the patient or legally authorized representative.