Data-driven Development of a Core Dataset for Difficult Airway Alerts

NCT07275567 | Active Not Recruiting

• 1 other identifier: 2024-300503-WF
• Study Type: observational
• Target: 1,785
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intubation; Difficult or Failed; Airway Management; Airway Complication of Anesthesia

Keywords

Difficult airway alerts; Airway alert cards; Airway documentation; Electronic health records

Outcome Measures

Primary Outcomes (1)

• Difficult airway alert

  Documented by the airway operator following tracheal intubation (y/n)

  1 hour

Secondary Outcomes (2)

• Recommendation for awake tracheal intubation

  1 hour

• Recommendation for camera-assisted tracheal intubation

  1 hour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing general anesthesia with tracheal intubation
• Informed consent obtained
• Age \> 18 years

You may not qualify if:

• Indication for intubation via a bronchoscope or awake intubation
• Pregnant women

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology, Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (3)

• 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.

  PMID: 36006056 RESULT

• 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.

  PMID: 38789407 RESULT

• 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.

  PMID: 40310618 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: April 1, 2019
• Primary Completion: July 31, 2023
• Study Completion: November 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

DE (1)