Allergic ReactionADVENTURENCT05185479
Analysis of Adverse Events in Anesthesia Using Artificial Intelligence
An observational study of Allergic Reaction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Allergic Reaction
- How many people
- 9,559 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2020to 12 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Analysis of ADVerse evENTs in Anesthesia Using ARtificial IntelligencE
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
- Conditions
- Allergic Reaction
- Keywords
- Allergic Reaction, Adverse events, Health database, Natural Language Processing
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Files analysed retrospectively from January 01, 2009 to June 30, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start12 Nov 2020
- Primary completion12 Oct 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9,559 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul-Michel MERTES, MD, PhD, Principal investigator, Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185479
- Sponsor's protocol ID
- 8505
- Acronym
- ADVENTURE
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38718923
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of ADVerse evENTs in Anesthesia Using ARtificial IntelligencE
- ClinicalTrials.gov ID
- NCT05185479
- Acronym / sponsor ID
- ADVENTURE / 8505
- Conditions
- Allergic Reaction
- Keywords
- Allergic Reaction, Adverse events, Health database, Natural Language Processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,559 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patient not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis.
Time frame: Files analysed retrospectively from January 01, 2009 to June 30, 2020 will be examined]
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 38718923Mertes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul-Michel MERTES, MD, PhD principal investigator
Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Reaction, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis. (time frame: Files analysed retrospectively from January 01, 2009 to June 30, 2020 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.