Intubation ComplicationDA-VITIONNCT05884645
The DAnish VIdeo IntubaTION (DA-VITION) Study
An observational study of Intubation Complication and Intubation; Difficult or Failed, run by Lise Aunsholt at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intubation Complication, Intubation; Difficult or Failed
- What is being tested?
- Video-directed endotracheal intubation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 10,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will include patients across all ages are eligible for inclusion if they are undergoing video-directed oral or nasal endotracheal intubation in the Capital Region of Denmark.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 1 recruiting
- Active, not recruiting
Rigshospitalet
Copenhagen, 2100
- Recruiting
Capital Region of Denmark
Copenhagen
Niklas Breindahl, MD, +4528566410, niklas.breindahl@regionh.dk
Lise Aunsholt, MD, PhD, lise.aunsholt@regionh.dk
About this study
Official title: The DAnish VIdeo IntubaTION (DA-VITION) Study: a Prospective Observational Cohort Study
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.
Read the 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.
- Being tested
- Video-directed endotracheal intubation
- Keywords
- video-guided endotracheal intubation, artificial intelligence, videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-directed endotracheal intubationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing endotracheal intubation | Patients across all ages undergoing endotracheal intubation. Receives: Procedure: Video-directed endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway.
Measured: 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.
Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway.
Measured: 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.
AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway.
Measured: The landmarks will be identified on the multimedia file from the procedure.
Secondary outcomes (7)
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.
Measured: During the procedure.
Number of attempts.
The number of attempts (one, two, and three or more).
Measured: During the procedure.
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.
Measured: During the procedure.
Overall course success.
Overall course success is defined as successful intubation by any provider on any attempt within that course.
Measured: During the procedure.
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.
Measured: During the procedure.
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.
Measured: 72 hours after the procedure
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).
Measured: 72 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lise Aunsholt
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Academy for Medical Education and Simulation
- Responsible party
- Sponsor-investigator, Lise Aunsholt, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Niklas Breindahl, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884645
- Sponsor's protocol ID
- The DA-VITION study
- Acronym
- DA-VITION
- Status last verified
- Sep 2024
- First submitted
- 23 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Capital Region in Denmark retains all rights to the collected data, which must not be shared without approval.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DAnish VIdeo IntubaTION (DA-VITION) Study: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05884645
- Acronym / sponsor ID
- DA-VITION / The DA-VITION study
- Keywords
- video-guided endotracheal intubation, artificial intelligence, videolaryngoscope
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Lise AunsholtUniversity, hospital or other
- Collaborators
- Copenhagen Academy for Medical Education and Simulation
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing endotracheal intubation | – | Procedure: Video-directed endotracheal intubationPatients across all ages undergoing endotracheal intubation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will include patients across all ages are eligible for inclusion if they are undergoing video-directed oral or nasal endotracheal intubation in the Capital Region of Denmark.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-directed endotracheal intubationThere 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. | Procedure or surgery | Patients undergoing endotracheal intubation |
Primary outcome
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.
Accuracy 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.
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.
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.
Specificity 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.
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.
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. The Capital Region in Denmark retains all rights to the collected data, which must not be shared without approval.
Related trials for Intubation Complication
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Intubation Complication
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The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niklas Breindahl, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation Complication and Intubation; Difficult or Failed, run by Lise Aunsholt at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niklas Breindahl, MD (+4528566410, niklas.breindahl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.