ClinicalTrials.gg
RecruitingNCT07922044MEASURE-ILDUpdated Nov 6, 2026

Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use

An interventional study of AI-video laryngoscopy (AIVL) and Conventional Video Laryngoscope (VL) in Critically Ill Patients Requiring Mechanical Ventilation, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators are developing a video laryngoscope equipped with artificial intelligence technology to enable automatic identification of key airway anatomical structures and real-time guidance during intubation, with the aim of improving the success rate and efficiency of endotracheal intubation in emergency settings.

02

Conditions studied

  • Critically Ill Patients Requiring Mechanical Ventilation

Keywords

  • Artificial Intelligence
  • Video Laryngoscopy
  • YOLO
  • endotracheal intubation
  • deep learning
03

In context

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient inclusion criteria: Adult patients in critical condition requiring endotracheal intubation via laryngoscopy (age ≥ 18 years).

Exclusion criteria

Exclusion Criteria:

  • pregnant women, prisoners, recent history of airway surgery, oral or pharyngeal malformations, inability to perform randomization due to the need for emergency endotracheal intubation, or when the investigator deemed it necessary or to use AIVL, VL, or DL during the first intubation attempt.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Video Laryngoscope(VL)

    Participants randomized to this arm (n=60) will undergo the first endotracheal intubation attempt using a conventional video laryngoscope (VL), without AI-assisted anatomical identification or intubation guidance.

    Device: Conventional Video Laryngoscope (VL)

  • Experimental
    AI-assisted Video Laryngoscope (AIVL)

    Participants randomized to this arm (n=60) will undergo the first endotracheal intubation attempt using an AI-assisted video laryngoscope (AIVL), which provides real-time identification of airway anatomical structures and intubation guidance. Operators will receive standardized training on the device controls, guidance interface, and image display before use. Operators may decide whether to follow the AI guidance.

    Device: AI-video laryngoscopy (AIVL)

Interventions

  • DeviceAI-video laryngoscopy (AIVL)

    When using the AIVL for the first attempt at laryngoscopy intubation, the operator shall receive pre-procedural training, which primarily covers the functional buttons, the prompt interface, and image display.

  • DeviceConventional Video Laryngoscope (VL)

    A conventional video laryngoscope will be used for the first endotracheal intubation attempt. The device displays the airway image without AI-assisted identification of anatomical structures or real-time AI intubation guidance.

06

What researchers measure

Primary outcomes

  1. First-pass intubation success rate

    Proportion of participants with successful endotracheal tube placement on the first laryngoscopic attempt, confirmed by end-tidal carbon dioxide monitoring.

    Time frame: The time from enrollment to completion of intubation (usually within 10 minutes).

Secondary outcomes

  1. Intubation time

    Time in seconds from insertion of the laryngoscope into the oral cavity until the endotracheal tube passes through the glottis.

    Time frame: The time from enrollment to completion of intubation (usually within 10 minutes).

  2. Severe complications occurring within 2 minutes after intubation were defined as severe hypoxemia (peripheral SpO₂ <80%), severe hypotension (systolic blood pressure <65 mmHg), initiation of vasoactive agents, cardiac arrest, or death.

    Time frame: From enrollment to the 2 minutes after intubation

  3. AI recall

    True-positive anatomical detections divided by true-positive plus false-negative detections, assessed against reference annotations.

    Time frame: The time from enrollment to completion of intubation (usually within 10 minutes).

  4. Duration of mechanical ventilation

    Duration of mechanical ventilation, measured in days.

    Time frame: From enrollment to the end of treatment at 8 weeks

  5. 28-day all-cause mortality

    Proportion of participants who die from any cause within 28 days after enrollment.

    Time frame: From enrollment through day 28.

  6. ICU length of stay

    Duration of intensive care unit stay, measured in days.

    Time frame: From enrollment through the end of treatment, up to 8 weeks.

  7. Total hospital length of stay

    Total duration of hospitalization, measured in days.

    Time frame: From enrollment through the end of treatment, up to 8 weeks.

  8. AI precision

    True-positive anatomical detections divided by true-positive plus false-positive detections, assessed against reference annotations.

    Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.

  9. AI specificity

    True-negative assessments divided by true-negative plus false-positive assessments, assessed against reference annotations.

    Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.

  10. AI F1 score

    Harmonic mean of precision and recall: 2 x precision x recall / (precision + recall).

    Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.

  11. Mean average precision (mAP)

    Mean of average precision across the evaluated anatomical classes against reference annotations.

    Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.

07

Study locations

2 of 2 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Nov 6, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07922044
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators
Shaoxing Central Hospital
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Jintao Wei wei
Contact
weijintao@zju.edu.cn
19560480512

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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