Intensive Care Unit SyndromeNCT06427265
Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study
An observational study of Intensive Care Unit Syndrome and Prediction, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial summary
This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit Syndrome, Prediction, Cognitive Impairment
- How many people
- 840 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Jun 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stage one involved studying patients discharged from the ICU and their families to investigate the occurrence and factors influencing post-intensive care syndrome (PICS), identifying various developmental patterns of PICS. A minimum sample size of 840 patients and 420 family members was established. Stage two focused on developing and evaluating a machine learning-based early warning model for PICS. The model construction utilized data from stage one, while the evaluation included 525 patients and 393 family members who met the exclusion criteria.
Who may be able to join
- Length of stay in ICU ≥24h;
- Age ≥18 years old;
- Conscious when leaving ICU, communicating with investigators without barriers;
- Informed consent. Family members：
- One family member ≥18 years of age was selected for each patient;
- Assume the main role of caring for patients and medical decision-making;
- No history of mental illness or other serious organic diseases;
- Informed consent and voluntary participation in this study.
Who cannot join
- Have been in ICU for more than 24h within 3 months before this admission;
- Transferred to another ICU;
- Cognitive impairment existed before ICU admission (BDRS > 4 points);
- Severe hearing impairment, dysarthria, etc., which cannot be followed up;
- Unable to complete the questionnaire survey due to serious illness.
- Family members:
- Family members refuse to participate in the study due to their own reasons;
- Severe hearing and language impairment, unable to cooperate with researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Tingrui WANG, 19117899885, W19117899885@163.com
About this study
This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.
- Conditions
- Intensive Care Unit Syndrome, Prediction, Cognitive Impairment, Sleep Disorder, Memory Disorders
- Keywords
- Post-icu syndrome, Prediction model, Development Trajectory
- Medical subject headings
- Cognitive Dysfunction, Sleep Wake Disorders, Memory Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation scale score
Patient:
- Post-icu syndrome assessment of ICU survivors: Healthy Aging Brain Care monitoring(HABC Monitor) score;
- ICU related Memory: Intensive Care Unit Memory Tool (ICUMT);
- Sleep quality: Richards-Campbell Sleep Questionnaire (RCSQ);
- Perceived Social Support Scale (PSSS).
Family members:
- Sleep quality of family members: Richards-Campbell Sleep Questionnaire (RCSQ);
- anxiety and Depression of family members: Hospital anxiety and Depression Scale score;
- Family fatigue: Scores of fatigue rating Scale;
- PTSD of family members: Event Impact Scale score;
Measured: 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Dec 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies 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
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese nursing association
- Responsible party
- Sponsor
- Investigators
- Li Yao, Study chair, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427265
- Sponsor's protocol ID
- ZHKYQ202316
- Other IDs
- No. ZHKYQ202316, No. Gyfynsfc[2023]35
- Status last verified
- Jun 2024
- First submitted
- 19 May 2024
- Last updated
- 31 May 2025
- 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study
- ClinicalTrials.gov ID
- NCT06427265
- Acronym / sponsor ID
- ZHKYQ202316
- Conditions
- Intensive Care Unit Syndrome, Prediction, Cognitive Impairment, Sleep Disorder, Memory Disorders
- Keywords
- Post-icu syndrome, Prediction model, Development Trajectory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese nursing association
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 May 2024 (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 project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stage one involved studying patients discharged from the ICU and their families to investigate the occurrence and factors influencing post-intensive care syndrome (PICS), identifying various developmental patterns of PICS. A minimum sample size of 840 patients and 420 family members was established. Stage two focused on developing and evaluating a machine learning-based early warning model for PICS. The model construction utilized data from stage one, while the evaluation included 525 patients and 393 family members who met the exclusion criteria.
Key inclusion criteria (8 listed)
- Length of stay in ICU ≥24h;
- Age ≥18 years old;
- Conscious when leaving ICU, communicating with investigators without barriers;
- Informed consent. Family members：
- One family member ≥18 years of age was selected for each patient;
Key exclusion criteria (8 listed)
- Have been in ICU for more than 24h within 3 months before this admission;
- Transferred to another ICU;
- Cognitive impairment existed before ICU admission (BDRS > 4 points);
- Severe hearing impairment, dysarthria, etc., which cannot be followed up;
- Unable to complete the questionnaire survey due to serious illness.
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
Correlation scale score
Time frame: 2024-2026
Patient: 1. Post-icu syndrome assessment of ICU survivors: Healthy Aging Brain Care monitoring(HABC Monitor) score; 2. ICU related Memory: Intensive Care Unit Memory Tool (ICUMT); 3. Sleep quality: Richards-Campbell Sleep Questionnaire (RCSQ); 4. Perceived Social Support Scale (PSSS). Family members: 1. Sleep quality of family members: Richards-Campbell Sleep Questionnaire (RCSQ); 2. anxiety and Depression of family members: Hospital anxiety and Depression Scale score; 3. Family fatigue: Scores of fatigue rating Scale; 4. PTSD of family members: Event Impact Scale score;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Li Yao study chair
The Affiliated Hospital Of Guizhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome and Prediction, run by The Affiliated Hospital Of Guizhou Medical University at 1 site 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 8 inclusion and 8 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 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingrui WANG (19117899885, W19117899885@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation scale score (time frame: 2024-2026). 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 31 May 2025.