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PARO-agitation-study

RecruitingNAAges 18 Years - anyAllHannover Medical School
NCT07568093 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Postoperative agitation is a common and serious complication in visceral and transplant surgery, associated with prolonged hospital stays and an increased risk of self-harm. Therefore, it is important to find an approach to improve the management of postoperative agitation and to reduce its duration and severity. The medical device "PARO" is a robotic seal that enables patient-robot-interaction. Patients respond to the device through verbal communication and motor responses, as well as facial expressions and gestures. The seal detects human interaction through audiovisual recognition, tactile sensors, and the integration of artificial intelligence. The aim of the study is to observe the use of "PARO" in patients undergoing elective visceral surgery and to analyze the occurence of agitation. A decrease in the incidence of postoperative agitation is to be expected in a cohort of patients

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📋 Eligibility rules (as published)
Patient inclusion criteria: * ≥18 years of age * Elective visceral surgery * german-speaking * Patient is capable of giving informed consent Patient exclusion criteria: * Known dementia * Known immunodeficiency * Anacusia * Acute damage to the central nervous system * A preoperative systemic infection * Pre-existing severe immunosuppression or colonization with multidrug-resistant organisms (methicillin resistant Staphylococcus aureus (MRSA), quadruple multidrug-resistant Gram-negative pathogens (MRGN), Candida auris, vancomycin-resistant enterococci (VRE), and linezolid-resistant enterococci (LRE)) * Postoperative systemic infection * Drug dependence * Known chronic pain syndrome
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What it tests

  • PARO
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Where

1 site
Medical School Hannover
Hanover, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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