Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

use of the robotic bed: use of the robotic bed LOLE.K for the early rehabilitation

Study summary

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.

Eligibility

Primary outcome measure(s)

• Effectiveness of LOLE.K reducing ICU and hospital stay — 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 — 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 — 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 — 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.

Trial sites (1)

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