Pilot Observational Cohort Study to Validate the Aiinane Preoperative and Preanesthesia Risk Assessment Tool in Real-world Conditions: Proof of Concept.
Trial ID: NCT07021235
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2025-03-03
Completion date: 2025-07-25
Sponsor: Ancor Serrano
Collaborators: Hospital Universitari de Bellvitge; Institut d'Investigació Biomèdica de Bellvitge
Conditions: Breast Neoplasms; Surgery Scheduled; Surgery Related Complications Rate; Preanesthetic Medication; Preoperative Patients; Preoperative Planning; Risk Assesment
Locations: Bellvitge University Hospital. ,
Countries: Spain
Enrollment: 30
Age range: 18 Years - None
Sex: ALL

Summary:
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 clinical decision-making in an automated digital preoperative environment. It helps assess patients and flags low-risk from medium/high-risk individuals, reporting personalized needs to the medical team. The software was developed exclusively by independent researchers from Bellvitge University Hospital and the Bellvitge Biomedical Research Institute (IDIBELL).

HYPOTHESIS: The tool has been tested successfully on fictitious patients in controlled preclinical scenarios. The aim now is a proof-of-concept study to verify its performance with real patients in uncontrolled, real-world settings.

This is a Clinical Performance Research Study, aligned with MDSW Clinical Evaluation Guidelines (MDR, MDCG 2020-1) for (EU) 2017/745, and authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the local Ethics Committee.

MAIN OBJECTIVE: The clinical trial aims to verify that the software (aiinane), supporting preanesthetic assessment and preoperative risk estimation, is fit for its intended purpose and performs as expected under normal conditions of use.

This is an observational, non-interventional, single-center, prospective, longitudinal adult cohort study. The target population is any adult (\>18 years) of any gender undergoing breast cancer surgery.

Eligibility criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years) of both sexes. Although breast neoplasia is a pathology with high prevalence in the female biological gender, we do not rule out recruiting patients of male biological gender.
* Who have been indicated for breast surgery to resolve breast cancer pathology.
* Who will undergo a pre-anesthetic evaluation during the inclusion period..
* Subjects must understand the nature of the study procedures and provide written informed consent prior to any study-related procedures.

Exclusion Criteria:

* Surgery scheduled for \<7 days from enrollment
* Inability to participate in the study, in the opinion of the investigator, due to, for example, severe brain damage, language barrier, dementia, or other clinically significant or unstable conditions.
* Subject's participation in any other clinical study.
* Subjects dependent (as employee or relative) of the promoter or researcher.
* Subjects placed in an institution by virtue of an order issued by either judicial or administrative authorities.
* Limited legal capacity or incapacity.
* Pregnancy.

Outcomes:
The aiinane tool is able to create a final report/document with the clinical information required for preoperative assessment