NCT Number: NCT05884645
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.
Interested in participating?
Request InfoAll sexes
Observational
Capital Region of Denmark, Copenhagen, Denmark
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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.
Time frame: The landmarks will be identified on the multimedia file from the procedure.
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: During the procedure.
A course is defined as one method for intubation (i.e., the same airway device, approach, and medication regimen). Many attempts by multiple providers are allowed within a given course as long as all attempts are made using the same method.
Time frame: During the procedure.
The number of attempts (one, two, and three or more).
Time frame: During the procedure.
Successful endotracheal intubation is defined as correct endotracheal tube placement in the trachea confirmed by chest rise, auscultation, waveform monitor for end-tidal CO2, and/or chest radiograph in first, second, or three attempts.10,19 First-attempt success is defined according to previous studies as successful intubation on the first attempt by the first provider. Success within two attempts is defined as successful intubation on the second attempt by the same provider. Success within 3 attempts is defined as successful intubation on any attempt by the same provider.
Time frame: During the procedure.
Overall course success is defined as successful intubation by any provider on any attempt within that course.
Time frame: During the procedure.
Severe oxygen desaturations are defined according to previous studies as a 20% or more decrease in oxygen saturation from the highest level immediately before the first attempt.
Time frame: 72 hours after the procedure
Non-severe TIAEs: Oesophageal intubation with immediate recognition, dysrhythmia including any duration of heart rate <60 beats per minute without chest compressions, main-stem bronchial intubation, emesis without aspiration, pain or agitation requiring additional medications causing a delay in intubation, epistaxis, lip trauma, dental injury, medication error, and hypertension.
Time frame: 72 hours after the procedure
Severe TIAEs: Cardiac arrest requiring chest compressions, oesophageal intubation with delayed recognition (defined as placement of the endotracheal tube into the oesophagus or hypopharynx with clinical deterioration, e.g., desaturation, before removal of the misplaced tube), emesis with aspiration, hypotension requiring therapy, laryngospasm, pneumothorax or pneumo-mediastinum, and direct airway injury (e.g., vocal cord injury, laryngeal injury, tracheal injury, false passage creation).
Contact information is provided by the study sponsor or research team.
Lise Aunsholt, MD, PhD
CONTACT
Niklas Breindahl, MD
CONTACT
Lise Aunsholt
Other
The DAnish VIdeo IntubaTION (DA-VITION) Study: a Prospective Observational Cohort Study
Acronym: DA-VITION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06322719
Acute Respiratory Failure, Intubation
Santiago de Compostela, A Coruña, Spain
View Trial DetailsNCT06727513
Airway Trauma, Intubation Complication
Beirut, Lebanon
View Trial DetailsNCT06401486
Anesthesia, Intubation Complication
A Coruña, Spain
View Trial DetailsNCT06232837
Endotracheal Intubation, Intubation Complication
Clermont-Ferrand, France
View Trial Details