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Proof of Concept of the Aiinane Preoperative Risk Assessment Tool.

NCT07021235 · Ancor Serrano · Updated 31 July 2025

What is being tested
Not stated
For
Breast Neoplasms; Surgery Scheduled; Surgery Related Complications Rate; Preanesthetic Medication; Preoperative Patients; Preoperative Planning; Risk Assesment
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 30 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 3 March 2025, ends 25 July 2025. Registered 13 June 2025.
Results
None posted yet.

In the researchers' words

BACKGROUND: Each year, over 13,000 patients in Catalonia and more than 4 million worldwide experience last-minute surgery cancellations (LMC) due to preoperative inefficiencies. As anaesthesia services struggle to meet surgical demands, thorough preoperative evaluations become challenging. Current resource-intensive pre-anaesthetic assessments are undermined by high demand, causing inefficiency. However, proper assessment identifies that most patients (\>70%) are low-risk and ensures high-risk patients are adequately prepared by analyzing risk profiles, health status, medical history, treatment, and lab results. RATIONALE: Previous attempts to improve preoperative risk assessment have mainly relied on self-administered questionnaires to detect at-risk patients. The investigators have identified a care model that enhances quality by adding value to preoperative risk assessment. By combining anaesthesiology expertise with AI techniques, the investigators developed an automated digital environment to detect risks, optimize visits, avoid cancellations, and reduce postoperative complications. This system uses parameterized medical knowledge to verify responses and objectively assess patient risk by integrating multiple data sources. The investigators have developed a Class IIa active diagnostic and monitoring product, a Medical Device Software (MDSW, EMDN V92), to support…
ClinicalTrials.gov, NCT07021235

Sites

  • Bellvitge University Hospital. ,L'Hospitalet de Llobregat, Barcelona, Spain