Menu
Recruiting NCT05884645

The DAnish VIdeo IntubaTION (DA-VITION) Study

— Observational Intubation Complication Intubation; Difficult or Failed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-directed endotracheal intubation.
Who it may be relevant to
Registry conditions: Intubation Complication, Intubation; Difficult or Failed. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The DAnish VIdeo IntubaTION (DA-VITION) Study: a Prospective Observational Cohort Study

Overview

This study aims to train an AI for video-directed endotracheal intubation (VITION) to recognise the anatomical structures of the upper airway during video-directed endotracheal intubations.

Detailed description

Study design

The VITION study protocol describes the design of a prospective, observational study. Inclusion will commence in 2023 at the anesthesia and intensive care departments in the Capital Region of Denmark.

Participants

Patients across all ages are eligible for inclusion if they are undergoing video-directed oral or nasal endotracheal intubation.

Exclusion criteria

Patients are excluded if they adhere to one of the exclusion criteria:

* Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis17,18). * Failed attempt by video laryngoscopy due to malfunctioning equipment. * Missing or corrupted video recording. * Informed consent is not obtained from the participants or participants' parents / legal guardians.

Interventions and comparisons

This prospective, observational study will have no interventions or comparisons.

Primary objective

The primary objective is to characterize anatomical landmarks and performances of intubations in a large and diverse pool of clinicians and patients.

Interventions

  • Procedure Video-directed endotracheal intubation
    There will be no intervention in this prospective observational cohort study. Endotracheal intubation is already used to secure the airway by placing an endotracheal tube into the trachea via the oral or nasal route. Indications include the need for airway control during general anaesthesia, mechanical ventilation, resuscitation, and various forms of acute respiratory distress.

Primary outcome measures

  • Accuracy of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Time frame: The landmarks will be identified on the multimedia file from the procedure.]
  • Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Time frame: The landmarks will be identified on the multimedia file from the procedure.]
  • Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Time frame: The landmarks will be identified on the multimedia file from the procedure.]
  • AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Time frame: The landmarks will be identified on the multimedia file from the procedure.]
Secondary outcome measures (7)
  • Time consumption of the course. [Time frame: During the procedure.]
  • Number of attempts. [Time frame: During the procedure.]
  • Successful endotracheal intubation. [Time frame: During the procedure.]
  • Overall course success. [Time frame: During the procedure.]
  • Severe oxygen desaturations [Time frame: During the procedure.]
  • Non-severe TIAEs [Time frame: 72 hours after the procedure]
  • Severe TIAEs [Time frame: 72 hours after the procedure]

Eligibility criteria

Patients are eligible if they adhere to all the following inclusion criteria:

● Undergoing video-directed oral or nasal endotracheal intubation.

Exclusion criteria

Patients are excluded if they adhere to one of the exclusion criteria:

  • Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis).
  • Failed attempt by video laryngoscopy due to malfunctioning equipment.
  • Missing or corrupted video recording.
  • Informed consent is not obtained from the participants or participants' parents / legal guardians.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 2 centers
  • Rigshospitalet — Copenhagen
  • Capital Region of Denmark — Copenhagen

Identifiers

NCT: NCT05884645 · The DA-VITION study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗