Effectiveness of Using Pet-Robotic Intervention to Enhance Spontaneous Breathing Trial Success in Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Behavioral responses
研究概览
简要总结
This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 -
- •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.
研究组 & 干预措施
Robotic pet (PARO) companionship
Participants will receive companionship from a robotic baby seal pet (PARO) during their spontaneous breathing trials. The intervention will be administered continuously throughout the entire duration of the spontaneous breathing trials period or until the participant meets predefined early termination criteria.
干预措施: Robotic pet (PARO) companionship (Behavioral)
Standard care
Participant in this arm will receive standard care.
结局指标
主要结局
Behavioral responses
时间窗: 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.
Behavioral responses will be assessed using the Motor Activity Assessment Score (MAAS). Data will be analyzed as both continuous and categorical variables. Continuous variable: mean MAAS score (range 0-6). Categorical variables: Sedated (MAAS 0-2); Cooperative (MAAS = 3); Agitated (MAAS 4-6).
Subjective Psychological response
时间窗: 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.
Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety).
Objective Psychological Response
时间窗: During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Crying or anger for more than five minutes (yes/no).
次要结局
- Signs of respiratory distress - heart rate(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(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(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(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(After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.)
- Duration of spontaneous breathing trial(After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.)
- Adverse events(From Day 1 of measurement until extubation, intensive care unit discharge, or early termination.)
- Extubation within 24 hours(Within 24 hours from Day 1 of measurement.)
- Experience of using robotic pet(3 days after extubation.)