NCT05185479

Brief Summary

The interest of health databases in anesthesia is no longer to be demonstrated. The aim of this research was to develop a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis: The main objective of the study was to identify what a "naïve" unsupervised model would discover based on Adverse Event (AE) descriptions. Our second goal was to identify apparently unrelated events whose combination could favor the occurrence of an AE

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,559

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 22, 2021

Last Update Submit

December 11, 2023

Conditions

Keywords

Allergic ReactionAdverse eventsHealth databaseNatural Language Processing

Outcome Measures

Primary Outcomes (1)

  • Development of a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis.

    The aim of this research was to develop a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis: The main objective of the study was to identify what a "naïve" unsupervised model would discover based on Adverse Event (AE) descriptions. Our second goal was to identify apparently unrelated events whose combination could favor the occurrence of an AE

    Files analysed retrospectively from January 01, 2009 to June 30, 2020 will be examined]

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Minors and adults having had an allergic reaction associated with care, and having had an adverse event reported by an anesthetist between January 01, 2009 and June 30, 2020

You may qualify if:

  • Minors and adults having had an allergic reaction associated with care
  • Having had an adverse event reported by an anesthetist between January 01, 2009 and June 30, 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

Related Publications (1)

  • Mertes PM, Morgand C, Barach P, Jurkolow G, Assmann KE, Dufetelle E, Susplugas V, Alauddin B, Yavordios PG, Tourres J, Dumeix JM, Capdevila X. Validation of a natural language processing algorithm using national reporting data to improve identification of anesthesia-related ADVerse evENTs: The "ADVENTURE" study. Anaesth Crit Care Pain Med. 2024 Aug;43(4):101390. doi: 10.1016/j.accpm.2024.101390. Epub 2024 May 6.

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Paul-Michel MERTES, MD, PhD

    Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

November 12, 2020

Primary Completion

October 12, 2021

Study Completion

November 12, 2021

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations