Airway ManagementFingAIRprintNCT07275567
Data-driven Development of a Core Dataset for Difficult Airway Alerts
An observational study of Airway Management and Intubation; Difficult or Failed, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Intubation; Difficult or Failed, Airway Complication of Anesthesia
- How many people
- 1,785 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing general anesthesia with tracheal intubation
- Informed consent obtained
- Age > 18 years
Who cannot join
- Indication for intubation via a bronchoscope or awake intubation
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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.
- Keywords
- Difficult airway alerts, Airway alert cards, Airway documentation, Electronic health records
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult airway alert
Documented by the airway operator following tracheal intubation (y/n)
Measured: 1 hour
Secondary outcomes (2)
Recommendation for awake tracheal intubation
Recommendation for future airway planning documented by the airway operator after tracheal intubation (y/n)
Measured: 1 hour
Recommendation for camera-assisted tracheal intubation
Recommendation for future airway planning documented by the airway operator after tracheal intubation (y/n)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Apr 2019
- Primary completion31 Jul 2023
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,785 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275567
- Sponsor's protocol ID
- 2024-300503-WF
- Acronym
- FingAIRprint
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36006056Kohl 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.
PubMed 38789407Popal 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.
PubMed 40310618
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07275567
- Acronym / sponsor ID
- FingAIRprint / 2024-300503-WF
- Keywords
- Difficult airway alerts, Airway alert cards, Airway documentation, Electronic health records
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,785 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Dec 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients undergoing general anesthesia with tracheal intubation
- Informed consent obtained
- Age > 18 years
Key exclusion criteria (2 listed)
- Indication for intubation via a bronchoscope or awake intubation
- Pregnant women
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
Difficult airway alert
Time frame: 1 hour
Documented by the airway operator following tracheal intubation (y/n)
2 secondary outcomes
Recommendation for awake tracheal intubation
Time frame: 1 hour
Recommendation for camera-assisted tracheal intubation
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 36006056Kohse 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.
- Results publication: PubMed 38789407Kohl 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.
- Results publication: PubMed 40310618Popal 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Airway Management and Intubation; Difficult or Failed, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difficult airway alert (time frame: 1 hour). 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 NCT07275567, which also lists 3 linked publications.
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 10 Dec 2025.