Intubation Complication Clinical Trial
— VITIONOfficial title:
Video Intelligence intubaTION (VITION): A Prospective Observational Study
Verified date | April 2024 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 5000 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Capital Region of Denmark | København | |
Denmark | Rigshospitalet | København |
Lead Sponsor | Collaborator |
---|---|
Lise Aunsholt | Copenhagen Academy for Medical Education and Simulation |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of the AI algorithm to recognise the anatomical landmarks in the upper airway. | Accuracy of the AI algorithm to recognise the anatomical landmarks in the upper airway. | The landmarks will be identified on the multimedia file from the procedure. | |
Primary | Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway. | Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway. | The landmarks will be identified on the multimedia file from the procedure. | |
Primary | Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway. | Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway. | The landmarks will be identified on the multimedia file from the procedure. | |
Primary | AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway. | AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway. | The landmarks will be identified on the multimedia file from the procedure. | |
Secondary | Time consumption of the course. | 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. | During the procedure. | |
Secondary | Number of attempts. | The number of attempts (one, two, and three or more). | During the procedure. | |
Secondary | Successful endotracheal intubation. | 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. | During the procedure. | |
Secondary | Overall course success. | Overall course success is defined as successful intubation by any provider on any attempt within that course. | During the procedure. | |
Secondary | Severe oxygen desaturations | 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. | During the procedure. | |
Secondary | Non-severe TIAEs | 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. | 72 hours after the procedure | |
Secondary | Severe TIAEs | 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). | 72 hours after the procedure |
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