- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07275567
Data-driven Development of a Core Dataset for Difficult Airway Alerts (FingAIRprint)
November 27, 2025 updated by: Universitätsklinikum Hamburg-Eppendorf
Data-driven Development of a Core Dataset for Documentation of Difficult Airway Alerts - a Secondary Analysis of Pooled Database From Three Prospective Studies - the FingAIRprint Project
Previous difficult airway management is the most accurate predictor of future difficulty.
Consistent documentation is paramount for future airway planning, but requires reliable, reproducible and easily accessible information.
Currently, anaesthesia alert cards are often based on analogue hard copies while they lack a clinically meaningful core data set allowing structured reproducible documentation and risk estimation.
Further, existing alert cards are often inconsistently used and clear triggers for issuing of airway alert cards are widely undefined.
The FingAIRprint project aims to develop a justifiable core data set using a data-driven approach in patients undergoing tracheal intubation with videolaryngoscopy or direct laryngoscopy, that is intended to be used for documentation of digital airway alerts.
Study Overview
Status
Active, not recruiting
Study Type
Observational
Enrollment (Actual)
1785
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany, 20246
- Department of Anesthesiology, Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Pooled database from three prospective studies originating from a single study center in adults undergoing elective head and neck surgery with general anaesthesia and tracheal intubation.
Description
Inclusion Criteria:
- Patients undergoing general anesthesia with tracheal intubation
- Informed consent obtained
- Age > 18 years
Exclusion Criteria:
- Indication for intubation via a bronchoscope or awake intubation
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difficult airway alert
Time Frame: 1 hour
|
Documented by the airway operator following tracheal intubation (y/n)
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recommendation for awake tracheal intubation
Time Frame: 1 hour
|
Recommendation for future airway planning documented by the airway operator after tracheal intubation (y/n)
|
1 hour
|
|
Recommendation for camera-assisted tracheal intubation
Time Frame: 1 hour
|
Recommendation for future airway planning documented by the airway operator after tracheal intubation (y/n)
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kohl V, Wunsch VA, Muller MC, Sasu PB, Dohrmann T, Peters T, Tolkmitt J, Dankert A, Krause L, Zollner C, Petzoldt M. Hyperangulated vs. Macintosh videolaryngoscopy in adults with anticipated difficult airway management: a randomised controlled trial. Anaesthesia. 2024 Sep;79(9):957-966. doi: 10.1111/anae.16326. Epub 2024 May 24.
- Kohse EK, Siebert HK, Sasu PB, Loock K, Dohrmann T, Breitfeld P, Barclay-Steuart A, Stark M, Sehner S, Zollner C, Petzoldt M. A model to predict difficult airway alerts after videolaryngoscopy in adults with anticipated difficult airways - the VIDIAC score. Anaesthesia. 2022 Oct;77(10):1089-1096. doi: 10.1111/anae.15841. Epub 2022 Aug 25.
- Popal Z, Sieg HH, Muller-Wiegand L, Breitfeld P, Dankert A, Sasu PB, Wunsch VA, Krause L, Zollner C, Petzoldt M. Decision-Making Tool for Planning Camera-Assisted and Awake Intubation in Head and Neck Surgery. JAMA Otolaryngol Head Neck Surg. 2025 Jun 1;151(6):585-594. doi: 10.1001/jamaoto.2025.0538.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
July 31, 2023
Study Completion (Estimated)
November 30, 2025
Study Registration Dates
First Submitted
November 27, 2025
First Submitted That Met QC Criteria
November 27, 2025
First Posted (Actual)
December 10, 2025
Study Record Updates
Last Update Posted (Actual)
December 10, 2025
Last Update Submitted That Met QC Criteria
November 27, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024-300503-WF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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