NCT06953414

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

April 22, 2025

Last Update Submit

May 1, 2025

Conditions

AnesthesiaAirway ManagementIntubation, IntratrachealBronchoscopyEndoscopes

Keywords

Airway managementClassificationFlexible endoscopy guided intubationFibroptic guided intubationRespiratory systemLaryngeal diseasesHealth records

Outcome Measures

Primary Outcomes (1)

  • Difficult awake flexible bronchoscopic intubation

    Difficult airway alert issued by the airway operator following ATI:FB

    1 hour

Secondary Outcomes (26)

  • First attempt success

    1 hour

  • Number of bronchoscopy attempts

    1 hour

  • Number of intubation attempts

    1 hour

  • Successful ATI:FB

    1 hour

  • Successful bronchoscopy

    1 hour

  • +21 more secondary outcomes

Eligibility Criteria

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

Patients with anticipated difficult airways scheduled for surgery with general anaesthesia and tracheal intubation at a single study center

You may qualify if:

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

You may not qualify if:

  • Patients not scheduled for ATI:FB
  • Pregnant or breastfeeding patients
  • Consent not given by the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 39108225BACKGROUND

  • 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.

    PMID: 37074950BACKGROUND

  • 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: 36006056BACKGROUND

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Martin Petzoldt, MD, FEAMS

    University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

  • Vera Köhl, MD

    University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Petzoldt, MD, FEAMS

CONTACT

04915222815932m.petzoldt@uke.de

Vera Köhl, MD

CONTACT

v.koehl@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

May 1, 2025

Study Start

April 30, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

May 6, 2025

Record last verified: 2025-04

Locations

DE(1)