Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Effectiveness of LOLE.K reducing ICU and hospital stay
研究概览
简要总结
The goal of this clinical trial is to evaluate whether LOLE.K, a new and specialized robotic bed, is effective in the rehabilitation of patients who have undergone surgery. The primary objectives of the trial are:
- Efficacy of LOLE.K: Does the LOLE.K robotic bed improve early rehabilitation in patients who undergone cardiac surgery?
- Impact on recovery: Does LOLE.K influence wound healing, muscle and neurological recovery, and psychological well-being?
To address these questions, the researchers will compare the use of LOLE.K with standard physical therapy to determine whether the robotic bed results in better outcomes in post-operative rehabilitation.
详细描述
The goal of this clinical trial is to learn whether LOLE.K, a new and specialized robotic bed, works for rehabilitation of patients following surgery.
The main research questions are:
- Is LOLE.K effictive in enhancing early rehabilitation among patients who have undergone cardiac surgery?
- Does LOLE.K influence wound healing, muscular and neurological recovery, and psychological well-being?
Researchers will compare LOLE.K bed to the usual therapy to see if LOLE.K woks better than standard post-operation rehabilitation.
- Project Objectives Primary Objective: To assess the effectiveness of multirole robotic beds (LOLE.K) for early rehabilitation in cardiac surgery patients.
- Target Population Patients: individuals aged 60-85 years undergoing aortic and mitral valve surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing aortic and mitral vale surgery
- •patients aged between 60 and 85
排除标准
- •Age < 18 years old
- •inability to provide informed consent, either verbally or in writing, or unwillingness to participate in systematic follow-up
- •Life expectancy < 1 year
- •Recent myocardial infarction (MI) with ST segment elevation (< 72 hours)
- •Left ventricular ejection fraction < 30%
- •Clearance della creatinina < 30 ml/min. Further exclusion criteria included bed rest orders, patients in a palliative care setting or with therapy limitations.
- •Restrictions due to the device were height outside the ranfe of 190cm, weight outside the range of 115kg, pacemakers, other electrical stimulators, or implanted medical pumps.
结局指标
主要结局
Effectiveness of LOLE.K reducing ICU and hospital stay
时间窗: 12 months
The autors proposal aims to reducing the ICU and Hospital stay in cardiac surgery patients through mobilization and postural drainage. The authors aim to discharge patients from the ICU within two days of surgery and discharge them from the hospital within two weeks. Therefore, the unit of measurement is expressed in the number of days elapsed from admission to discharge, both from the intensive care unit and from the hospital overall.
Effectiveness of LOLE.K reducing ICU and hospital stay
时间窗: 12 months
The autors proposal aims to reducing the ICU and Hospital stay in cardiac surgery patients through mobilization and postural drainage. The authors aim to discharge patients from the ICU within two days of surgery and discharge them from the hospital within two weeks. Therefore, the unit of measurement is expressed in the number of days elapsed from admission to discharge, both from the intensive care unit and from the hospital overall.
Effectiveness of LOLE.K reducing duration of Mechanical ventilation
时间窗: 12 months
One of the primary objectives of this study is to achieve a reduction in the duration of mechanical ventilation compatibly with each patient's specific preoperative and postoperative conditions. In addition to the invasive ventilation phase (ventilator), a reduction in the use of non-invasive ventilation (NIV) is also sought during the immediate postoperative period, up to seven days after surgery. The unite of measurement is the number of days the patient requires non-invasive ventilation following extubation.
Effectiveness of LOLE.K enhancing functional outcomes
时间窗: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
To assess physical functioning and the associated return to usual activities, the 36-Item Short Form Health Survey version 2 (SF-36 v2) , will be administered 12 weeks after surgery. This questionnaire measures a wide range of symptoms, experiences, and health outcomes across eight domains comprising thirty-six items, addressing gaps in the assessment of patient-reported outcomes throughout the care continuum. The unit of measurement is the SF-36 domain score (0-100).
Effectiveness of LOLE.K in patient satisfaction
时间窗: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
To characterize patient satisfaction, we will record pain, anxiety, and satisfaction levels during mobilization, all assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 represents the worst pain imaginable. Therefore, the unit of measurement is expressed in points on a 0-10 scale.
次要结局
- Muscular and neurological recovery(Maximum 12 months for the entire study, from enrollment to 6 months after discharge)
- Neurological and psychological well-being(Maximum 12 months for the entire study, from enrollment to 6 months after discharge)
- wound healing(12 months)
研究者
Gennaro Galasso
Professor of cardiology
University of Salerno