NCT06617403

Brief Summary

Supraglottic airway devices (SGA) are a safe and well-established technique for airway management. Nowadays, up to 60% of general anaesthetics performed in European countries use SGA. In 0.2-4.7% SGA fail and require conversion to tracheal tubes. The ERICA study will use artificial intelligence methods to develop a model that can predict the risk of an unplanned SGA conversion based on pre-operative characteristics available during the premedication visit.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 25, 2024

Last Update Submit

September 25, 2024

Conditions

Anesthesia, GeneralPostoperative ComplicationsLaryngeal MasksTreatment Failure

Keywords

"Neural Networks, Computer Artificial Intelligence"[Mesh]"Laryngeal Masks"[Mesh]"Treatment Failure"[Mesh]"Treatment Outcome"[Mesh]"Risk Factors"[Mesh]

Outcome Measures

Primary Outcomes (1)

  • Risk of unplanned SGA conversion

    intraoperative

Interventions

nonOTHER

non

Eligibility Criteria

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

Adult patients (≥18 years) receiving non-cardiac surgery using a supraglottic airway device

You may qualify if:

  • Adult patients (≥18 years) receiving general anaesthesia for non-cardiac surgery with a supraglottic airway device

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Technical University Munich

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

December 1, 2022

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations

DE(2)