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Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

NCT ID: NCT06953414

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

313 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-01-31

Brief Summary

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Airway management problems are key drivers for anesthesia-related adverse events. Awake tracheal intubation using flexible bronchoscopes with preserved spontaneous breathing (ATI:FB) is a recommended technique to manage difficult tracheal intubation in anesthesia, intensive care and emergency medicine. However, a prospective developed classification for this type of airway management is lacking. Due to the absence of a specifically tailored, validated classification for awake intubation with flexible bronchoscopes, many airway operators and institutions use classification tools that were originally developed for direct laryngoscopy, such as the percentage of glottic opening (POGO) score or Cormack-Lehane classification, although their diagnostic performance for the classification of ATI:FB is unknown. This prospective model development and validation study aims to develop two multivariable prediction models: a diagnostic prediction model to classify difficult ATI:FB after ATI:FB has been performed and a second prognostic prediction model to predict the risk for difficult ATI:FB before ATI:FB is performed. An additional aim is to develop a machine learning algorithm to evaluate ATI:FB.

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Detailed Description

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Conditions

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Anesthesia Airway Management Intubation, Intratracheal Bronchoscopy Endoscopes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with an anticipated difficult airways scheduled for ATI:FB
* Consent by the patient
* Minimum 18 years of age

Exclusion Criteria

* Patients not scheduled for ATI:FB
* Pregnant or breastfeeding patients
* Consent not given by the patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Petzoldt, MD, FEAMS

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

Vera Köhl, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Petzoldt, MD, FEAMS

Role: CONTACT

[email protected]
04915222815932

Vera Köhl, MD

Role: CONTACT

[email protected]

Facility Contacts

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Martin Petzoldt, MD

Role: primary

[email protected]
04915222815932

References

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Dohrmann T, Gutsche N, Kramer R, Zeidler EM, Roher K, Wunsch VA, Dankert A, Krause L, Zollner C, Sasu PB, Petzoldt M. Prospective development and validation of a universal classification for paediatric videolaryngoscopic tracheal intubation: the PeDiAC score. Anaesthesia. 2024 Nov;79(11):1201-1211. doi: 10.1111/anae.16394. Epub 2024 Aug 7.

Reference Type BACKGROUND
PMID: 39108225 (View on PubMed)

Barclay-Steuart A, Grosshennig HL, Sasu P, Wunsch VA, Stadlhofer R, Berger J, Stark M, Sehner S, Zollner C, Petzoldt M. Transnasal Videoendoscopy for Preoperative Airway Risk Stratification: Development and Validation of a Multivariable Risk Prediction Model. Anesth Analg. 2023 Jun 1;136(6):1164-1173. doi: 10.1213/ANE.0000000000006418. Epub 2023 Apr 19.

Reference Type BACKGROUND
PMID: 37074950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36006056 (View on PubMed)

Other Identifiers

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2025-101447-BO-ff

Identifier Type: -

Identifier Source: org_study_id

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