Critically Ill Patients Requiring Mechanical VentilationMEASURE-ILDNCT07922044
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
A study testing AI-video laryngoscopy (AIVL) and Conventional Video Laryngoscope (VL) in people with Critically Ill Patients Requiring Mechanical Ventilation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients Requiring Mechanical Ventilation
- What is being tested?
- AI-video laryngoscopy (AIVL) and Conventional Video Laryngoscope (VL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient inclusion criteria: Adult patients in critical condition requiring endotracheal intubation via laryngoscopy (age ≥ 18 years).
Who cannot join
- 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 contraindicated to use AIVL, VL, or DL during the first intubation attempt.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang
Jintao Wei, +86 19560480512, weijintao@zju.edu.cn
- Recruiting
Shaoxing Central Hospital
Shaoxing, Zhejiang, 312000
dongzhi liu, weijintao@zju.edu.cn
About this study
Official title: Development of an Intelligent Video Laryngoscope and Preliminary Verification for Emergency Application
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.
- Being tested
- AI-video laryngoscopy (AIVL), Conventional Video Laryngoscope (VL)
- Keywords
- Artificial Intelligence, Video Laryngoscopy, YOLO, endotracheal intubation, deep learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-video laryngoscopy (AIVL)Device
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.
Conventional Video Laryngoscope (VL)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Video Laryngoscope(VL) | Active comparator | 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. Receives: Device: Conventional Video Laryngoscope (VL) |
| AI-assisted Video Laryngoscope (AIVL) | Experimental | 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. Receives: Device: AI-video laryngoscopy (AIVL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The time from enrollment to completion of intubation (usually within 10 minutes).
Secondary outcomes (11)
Intubation time
Time in seconds from insertion of the laryngoscope into the oral cavity until the endotracheal tube passes through the glottis.
Measured: The time from enrollment to completion of intubation (usually within 10 minutes).
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.
Measured: From enrollment to the 2 minutes after intubation
AI recall
True-positive anatomical detections divided by true-positive plus false-negative detections, assessed against reference annotations.
Measured: The time from enrollment to completion of intubation (usually within 10 minutes).
Duration of mechanical ventilation
Duration of mechanical ventilation, measured in days.
Measured: From enrollment to the end of treatment at 8 weeks
28-day all-cause mortality
Proportion of participants who die from any cause within 28 days after enrollment.
Measured: From enrollment through day 28.
ICU length of stay
Duration of intensive care unit stay, measured in days.
Measured: From enrollment through the end of treatment, up to 8 weeks.
Total hospital length of stay
Total duration of hospitalization, measured in days.
Measured: From enrollment through the end of treatment, up to 8 weeks.
AI precision
True-positive anatomical detections divided by true-positive plus false-positive detections, assessed against reference annotations.
Measured: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
AI specificity
True-negative assessments divided by true-negative plus false-positive assessments, assessed against reference annotations.
Measured: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
AI F1 score
Harmonic mean of precision and recall: 2 x precision x recall / (precision + recall).
Measured: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
Mean average precision (mAP)
Mean of average precision across the evaluated anatomical classes against reference annotations.
Measured: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Patients Requiring Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922044
- Sponsor's protocol ID
- 2026-0142
- Acronym
- MEASURE-ILD
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Intelligent Video Laryngoscope and Preliminary Verification for Emergency Application
- ClinicalTrials.gov ID
- NCT07922044
- Acronym / sponsor ID
- MEASURE-ILD / 2026-0142
- Keywords
- Artificial Intelligence, Video Laryngoscopy, YOLO, endotracheal intubation, deep learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shaoxing Central Hospital
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Laryngoscope(VL) | Active comparator | Device: Conventional 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. |
| AI-assisted Video Laryngoscope (AIVL) | Experimental | Device: AI-video laryngoscopy (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient inclusion criteria: Adult patients in critical condition requiring endotracheal intubation via laryngoscopy (age ≥ 18 years).
Key exclusion criteria (1 listed)
- 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 contraindicated to use AIVL, VL, or DL during the first intubation attempt.
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 |
|---|---|---|
| AI-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. | Device | AI-assisted Video Laryngoscope (AIVL) |
| Conventional 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. | Device | Video Laryngoscope(VL) |
Primary outcome
First-pass intubation success rate
Time frame: The time from enrollment to completion of intubation (usually within 10 minutes).
Proportion of participants with successful endotracheal tube placement on the first laryngoscopic attempt, confirmed by end-tidal carbon dioxide monitoring.
11 secondary outcomes
Intubation time
Time frame: The time from enrollment to completion of intubation (usually within 10 minutes).
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
AI recall
Time frame: The time from enrollment to completion of intubation (usually within 10 minutes).
Duration of mechanical ventilation
Time frame: From enrollment to the end of treatment at 8 weeks
28-day all-cause mortality
Time frame: From enrollment through day 28.
ICU length of stay
Time frame: From enrollment through the end of treatment, up to 8 weeks.
Total hospital length of stay
Time frame: From enrollment through the end of treatment, up to 8 weeks.
AI precision
Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
AI specificity
Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
AI F1 score
Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
Mean average precision (mAP)
Time frame: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-video laryngoscopy (AIVL) and Conventional Video Laryngoscope (VL) in people with Critically Ill Patients Requiring Mechanical Ventilation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jintao Wei wei (19560480512, weijintao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-pass intubation success rate (time frame: The time from enrollment to completion of intubation (usually within 10 minutes).). 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 6 Nov 2026.