Anesthesia and Critical Care Registry

Recruiting

• Conditions: Anesthesia; Critical Care

• Registration Number: NCT06033404
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing for the refinement of monitoring techniques, therapies, and local-regional anesthesia maneuvers, and for the extension of care to a larger number of patients, including those previously excluded due to advanced age or comorbidities. Similarly, Intensive care management has continuously evolved, following innovations in the field of drugs and with the great diffusion of extracorporeal supports. The fundamental importance of registry studies has been recognized in this context to rapidly generate reliable data and improve the quality of care.

This prospective observational study is aimed at collecting data of all patients (expected 300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards.

Detailed Description

The study aims to collect data on 300,000 patients who undergo anesthesia and/or resuscitation procedures at the IRCCS San Raffaele Scientific Institute over a 10 years period. The information collected will include demographic data, anthropometric data, past and/or current clinical history of the patient, anamnestic clinical-instrumental data related to the anesthetic activity, data on therapeutic measures taken during stay in intensive care units, laboratory parameters, diagnostic tests, therapeutic procedures carried out during hospitalization, patient satisfaction, and evaluation scales. All this data will be anonymized prior insertion in the database, with the aim of creating a registry that can be used for scientific research. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards. The duration of observation of each patient will be variable, depending on the length of hospital stay and/or the duration of the diagnostic-therapeutic process. The analysis will follow the clinical course of patients from admission to hospital discharge, with the possibility of conducting telephone follow-ups for certain categories of patients after 1 year. Statistical analyses will be performed by grouping or describing patients based on their characteristics or in relation to the type of anesthetic and resuscitation procedures they undergo.

This study will follow the ethical principles outlined in the Helsinki Declaration and the current regulations for Observational Studies. All patients will be fully informed about the aspects of the study and their written informed consent will be required before participation.

Participation in the study is voluntary and free. No additional costs are expected for data collection and analysis: given the observational nature of the study, insurance coverage is not required.

Study Timeline

• Study Start: 2023-07-12
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2033-09
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

• Patients undergoing Anesthesia or Critical care
• Signed informed consent.

Exclusion Criteria

Refused informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcomes of patients urdergoing anesthesia and/or critical care	hospital discharge (usually <=30 days)	This study will collect data on the anesthesia-related and hospital outcome of patients undergoing anesthesia and intensive care. Due to the large sample size and heterogeneity of populations, further analysis will be planned to address homogenenous subgroups of patients.

Trial Locations

Locations (1)

Ospedale San Raffaele di Milano; 🇮🇹 Milan, MI, Italy