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Идёт набор NCT07163247

Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients

Без фазы С лечением Spontaneous Breathing Trial in ICU Spontaneous Breathing Trial

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: Robotic pet (PARO) companionship.
Кому может быть актуально
Состояния в реестре: Spontaneous Breathing Trial in ICU, Spontaneous Breathing Trial. 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
Тайвань
Следующий шаг
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Официальное название

Effectiveness of Using Pet-Robotic Intervention to Enhance Spontaneous Breathing Trial Success in Intensive Care Unit Patients

Обзор

This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.

Подробное описание

This study aims to investigate the effectiveness of pet robotic intervention during spontaneous breathing trials in adult patients admitted to medical intensive care units. The study explores whether this intervention can alleviate patients' anxiety during the weaning process, as well as enhance successful spontaneous breathing trials and facilitate further extubation.

Вмешательства

  • Поведенческое Robotic pet (PARO) companionship
    The intervention is composed of the following components: Duration: Robotic pet companionship lasting 30-120 minutes, depending on clinical goals during each spontaneous breathing trial (SBT). Preparation and interaction: PARO is introduced 30 minutes before each SBT to establish emotional connection. Study staff will briefly introduce its interactive features, including responding to stroking, gentle tapping, head movements, and eye blinking. Participants may interact freely with PARO during

Первичные конечные точки

  • Behavioral responses [Срок оценки: Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 until extubation, intensive care unit discharge, or early termination.]
  • Subjective Psychological response [Срок оценки: Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Objective Psychological Response [Срок оценки: During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
Вторичные конечные точки (9)
  • Signs of respiratory distress - heart rate [Срок оценки: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Signs of respiratory distress - blood pressure [Срок оценки: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Signs of respiratory distress - respiratory rate [Срок оценки: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Signs of respiratory distress - oxygen saturation [Срок оценки: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Spontaneous breathing trial outcome [Срок оценки: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Duration of spontaneous breathing trial [Срок оценки: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Adverse events [Срок оценки: From Day 1 of measurement until extubation, intensive care unit discharge, or early termination.]
  • Extubation within 24 hours [Срок оценки: Within 24 hours from Day 1 of measurement.]
  • Experience of using robotic pet [Срок оценки: 3 days after extubation.]

Критерии участия

Критерии включения

  • Aged 18 years or older with clear consciousness.
  • Mechanical ventilation for more than 72 hours.
  • Previously failed the first spontaneous breathing trial and is clinically ready to undergo a second spontaneous breathing trial.

Критерии исключения

  • Multidrug-resistant organism infection.
  • Requiring airborne infection isolation precautions (e.g., COVID-19).
  • Immunodeficiency (absolute neutrophil count < 500 cells/mL).
  • Richmond Agitation-Sedation Scale (RASS) less than -1.
  • Patient with a tracheostomy.
  • Subjects with implanted cardiac devices (e.g., permanent pacemaker, implantable cardioverter defibrillators)
  • Known allergy to the fur of the robotic pet.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07163247 · 202505120RINC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗