DeliriumNCT07337356
Research on the Development and Validation of an Early Prediction Model for Delirium
An observational study of Delirium and Prediction Models, run by Ruijin Hospital.
Trial summary
Delirium has a high incidence rate and significantly affects patient prognosis. Diagnosis often relies on manual assessment, which is subject to strong subjectivity, high rates of missed diagnosis, and poor stability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Prediction Models, Machine Learning
- How many people
- 795 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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
Study population: Adult patients (≥18 years old) admitted to the ICU of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, including elderly patients, those post-surgery, with sepsis, and trauma, which are common high-risk populations for delirium.
Who may be able to join
- Age ≥ 18 years, expected ICU stay ≥ 24 hours, and informed consent to participate in this study;
Who cannot join
- Patients with severe facial trauma/deformities that prevent complete expression acquisition, and patients with a history of emotional problems (such as anxiety, depression, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Research on the Development and Validation of an Early Prediction Model for Delirium Based on Machine Vision Analysis
Delirium has a high incidence rate and significantly affects patient prognosis. Diagnosis often relies on manual assessment, which is subject to strong subjectivity, high rates of missed diagnosis, and poor stability. This study employs non-contact identification technology based on machine vision analysis to quantitatively analyze characteristic biological feature data such as micro-expressions. It then investigates the correlation between these features and delirium subtypes. By integrating clinical phenotypic data and using machine learning algorithms, a multi-modal early prediction model for delirium is constructed to meet the clinical need for early warning of delirium subtypes and enhance the efficacy of delirium identification.
- Conditions
- Delirium, Prediction Models, Machine Learning
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational | 1. Meets the delirium diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), which requires the concurrent presence of: ① disturbance in awareness (reduced clarity of awareness of the environment) ; ② change in cognition (e.g., memory impairment, disorientation); 2. Undergoes consecutive daily assessments for 7 days using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at three time points (8:00, 14:00, 20:00) with an interval of ≥ 6 hours between each assessment, with at least two positive results; | |
| control | Admitted to the ICU during the same period, with negative results on consecutive daily CAM-ICU assessments for 3 days (three assessments per day as the observational group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with delirium as assessed by DSM-5
Zero is equivalent to no delirium and a high score means a higher occurrence of delirium
Measured: 7th day after ICU admission
Secondary outcomes (4)
Accuracy
Zero is equivalent to the minimum accuracy, while a value of 1 represents perfect accuracy
Measured: 7th day after ICU admission
Precision
The proportion of truly positive samples among those predicted as positive; the closer the score is to 1, the higher the precision
Measured: 7th day after ICU admission
Recall
The proportion of truly positive samples that are correctly predicted; the closer the score is to 1, the higher the diagnostic sensitivity
Measured: 7th day after ICU admission
F1-score
The harmonic mean of precision and recall; the higher the score, the better the diagnostic performance of the model
Measured: 7th day after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 795 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337356
- Sponsor's protocol ID
- ZWQ21886-2025-EC-579
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Development and Validation of an Early Prediction Model for Delirium Based on Machine Vision Analysis
- ClinicalTrials.gov ID
- NCT07337356
- Acronym / sponsor ID
- ZWQ21886-2025-EC-579
- Conditions
- Delirium, Prediction Models, Machine Learning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 795 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 13 Jan 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.
Delirium has a high incidence rate and significantly affects patient prognosis. Diagnosis often relies on manual assessment, which is subject to strong subjectivity, high rates of missed diagnosis, and poor stability. This study employs non-contact identification technology based on machine vision analysis to quantitatively analyze characteristic biological feature data such as micro-expressions. It then investigates the correlation between these features and delirium subtypes. By integrating clinical phenotypic data and using machine learning algorithms, a multi-modal early prediction model for delirium is constructed to meet the clinical need for early warning of delirium subtypes and enhance the efficacy of delirium identification.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observational | – | –1. Meets the delirium diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), which requires the concurrent presence of: ① disturbance in awareness (reduced clarity of awareness of the environment) ; ② change in cognition (e.g., memory impairment, disorientation); 2. Undergoes consecutive daily assessments for 7 days using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at three time points (8:00, 14:00, 20:00) with an interval of ≥ 6 hours between each assessment, with at least two positive results; |
| control | – | –Admitted to the ICU during the same period, with negative results on consecutive daily CAM-ICU assessments for 3 days (three assessments per day as the observational group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) admitted to the ICU of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, including elderly patients, those post-surgery, with sepsis, and trauma, which are common high-risk populations for delirium.
Key inclusion criteria (1 listed)
- Age ≥ 18 years, expected ICU stay ≥ 24 hours, and informed consent to participate in this study;
Key exclusion criteria (1 listed)
- Patients with severe facial trauma/deformities that prevent complete expression acquisition, and patients with a history of emotional problems (such as anxiety, depression, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with delirium as assessed by DSM-5
Time frame: 7th day after ICU admission
Zero is equivalent to no delirium and a high score means a higher occurrence of delirium
4 secondary outcomes
Accuracy
Time frame: 7th day after ICU admission
Precision
Time frame: 7th day after ICU admission
Recall
Time frame: 7th day after ICU admission
F1-score
Time frame: 7th day after ICU admission
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 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Prediction Models, run by Ruijin Hospital.
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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 weiqing Zhang Ph.D, Ph.D (8618521525300, weiq.zh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with delirium as assessed by DSM-5 (time frame: 7th day after ICU admission). 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 13 Jan 2026.