NCT06033404

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jul 2023Dec 2033

Study Start

First participant enrolled

July 12, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2033

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

10.1 years

First QC Date

September 4, 2023

Last Update Submit

August 5, 2025

Conditions

AnesthesiaCritical Care

Outcome Measures

Primary Outcomes (1)

  • Clinical outcomes of patients urdergoing anesthesia and/or critical care

    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.

    hospital discharge (usually <=30 days)

Interventions

Normal Clinical practicePROCEDURE

Normal Clinical practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patients undergoing Anesthesia or critical care -related maneuvers admitted to our hospital. All patients will follow their normal course of diagnosis/treatment without any further requirements for the scope of this study other than those provided in the normal management of patients with this condition. Furthermore, any decision regarding drug or procedure will be made by the physician based on her/his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study. No follow-up medical and/or imaging examinations/laboratory analysis after hospital discharge are needed by the present study design.

You may qualify if:

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

You may not qualify if:

  • Refused informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele di Milano

Milan, MI, 20132, Italy

RECRUITING

Related Publications (10)

  • Lanier WL. A three-decade perspective on anesthesia safety. Am Surg. 2006 Nov;72(11):985-9; discussion 1021-30, 1133-48. doi: 10.1177/000313480607201101.

    PMID: 17120937BACKGROUND

  • Desmarais P, Herrmann N, Alam F, Choi S, Avramescu S. Future Directions for Geriatric Anesthesiology. Anesthesiol Clin. 2019 Sep;37(3):581-592. doi: 10.1016/j.anclin.2019.05.002. Epub 2019 Jun 14.

    PMID: 31337487BACKGROUND

  • Belletti A, Palumbo D, Zangrillo A, Fominskiy EV, Franchini S, Dell'Acqua A, Marinosci A, Monti G, Vitali G, Colombo S, Guazzarotti G, Lembo R, Maimeri N, Faustini C, Pennella R, Mushtaq J, Landoni G, Scandroglio AM, Dagna L, De Cobelli F; COVID-BioB Study Group. Predictors of Pneumothorax/Pneumomediastinum in Mechanically Ventilated COVID-19 Patients. J Cardiothorac Vasc Anesth. 2021 Dec;35(12):3642-3651. doi: 10.1053/j.jvca.2021.02.008. Epub 2021 Feb 6.

    PMID: 33678544BACKGROUND

  • Liau A, Havidich JE, Onega T, Dutton RP. The National Anesthesia Clinical Outcomes Registry. Anesth Analg. 2015 Dec;121(6):1604-10. doi: 10.1213/ANE.0000000000000895.

    PMID: 26579661BACKGROUND

  • Shapiro FE, Jani SR, Liu X, Dutton RP, Urman RD. Initial results from the National Anesthesia Clinical Outcomes Registry and overview of office-based anesthesia. Anesthesiol Clin. 2014 Jun;32(2):431-44. doi: 10.1016/j.anclin.2014.02.018.

    PMID: 24882129BACKGROUND

  • Beane A, Salluh JIF, Haniffa R. What intensive care registries can teach us about outcomes. Curr Opin Crit Care. 2021 Oct 1;27(5):537-543. doi: 10.1097/MCC.0000000000000865.

    PMID: 34393177BACKGROUND

  • Arabi YM, Azoulay E, Al-Dorzi HM, Phua J, Salluh J, Binnie A, Hodgson C, Angus DC, Cecconi M, Du B, Fowler R, Gomersall CD, Horby P, Juffermans NP, Kesecioglu J, Kleinpell RM, Machado FR, Martin GS, Meyfroidt G, Rhodes A, Rowan K, Timsit JF, Vincent JL, Citerio G. How the COVID-19 pandemic will change the future of critical care. Intensive Care Med. 2021 Mar;47(3):282-291. doi: 10.1007/s00134-021-06352-y. Epub 2021 Feb 22.

    PMID: 33616696BACKGROUND

  • James A, De Jong A, Jeanmougin T, Blanie A, Figueiredo S, Goffin P, Le Guen M, Kantor E, Cipriani F, Campion S, Raux M, Jaber S, Futier E, Constantin JM; Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Characteristics and outcomes of patients undergoing anesthesia while SARS-CoV-2 infected or suspected: a multicenter register of consecutive patients. BMC Anesthesiol. 2022 Feb 14;22(1):46. doi: 10.1186/s12871-022-01581-0.

    PMID: 35164679BACKGROUND

  • Monaco F, Belletti A, Bove T, Landoni G, Zangrillo A. Extracorporeal Membrane Oxygenation: Beyond Cardiac Surgery and Intensive Care Unit: Unconventional Uses and Future Perspectives. J Cardiothorac Vasc Anesth. 2018 Aug;32(4):1955-1970. doi: 10.1053/j.jvca.2018.03.031. Epub 2018 Mar 20.

    PMID: 29709436BACKGROUND

  • Kelly FE, Fong K, Hirsch N, Nolan JP. Intensive care medicine is 60 years old: the history and future of the intensive care unit. Clin Med (Lond). 2014 Aug;14(4):376-9. doi: 10.7861/clinmedicine.14-4-376.

    PMID: 25099838BACKGROUND

Central Study Contacts

Marina Pieri, MD

CONTACT

+39022643pieri.marina@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Full Professor

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 13, 2023

Study Start

July 12, 2023

Primary Completion (Estimated)

September 1, 2033

Study Completion (Estimated)

December 1, 2033

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)