Critically Ill PatientsNCT06543602
the Multi-modal Evaluation of Agitation in Critically Ill Patients Based on Remote Video-Ultra-sensitive Detection Wave
An observational study of Critically Ill Patients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
The goal of this observational study is to learn about the effectiveness of the multi-modal evaluation for agitation behavior in critically ill patients based on remote video-Ultra-sensitive detection wave. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- multi-model monitoring and alert
- How many people
- 580 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2024to 30 Apr 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patients with agitation
Who may be able to join
- Patients at risk of agitation in the ICU
- Patients with RASS score -2 and above
- ≦ 65 years old, ≧ 18 years old
Who cannot join
- The affected party refused to participate in this study
- Missing/incomplete information
- Vulnerable groups such as pregnant women, those who lack the capacity for civil conduct and do not have the consent of their legal representatives
- Maxillofacial trauma, burns, tumors, surgery, etc. affect facial expression
- Patients with limb impairment and amputation
- Spinal cord injury, limb movement/sensory limitations
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- Patients with pre-existing neurological/psychiatric diseases
- Patients with malignant tumors
- Patients with infectious diseases
- Patients with terminal disease and dying disease
- Abnormal behavior due to head injury or craniocerebral disease
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, 1 recruiting
- Recruiting
the second affiliated hospital, Zhejiang University school of medicine
Hangzhou, Zhejiang, 310009
Zexin Chen, 8657187783821, zeyykyb@163.com
Yongan Xu, PhD& MD
- Active, not recruiting
SAHZU
Hanzhou, Zhejiang, 310009
About this study
Official title: A Multi-modal Recognition Model and Efficacy Evaluation for Agitation Behavior in Critically Ill Patients Based on Remote -Ultra-sensitive Detection Wave ---A Multi-center, Open-label, Observational Study
The goal of this observational study is to learn about the effectiveness of the multi-modal evaluation for agitation behavior in critically ill patients based on remote video-Ultra-sensitive detection wave.
The main question it aims to answer is: evaluate the effectiveness of multi-modal evaluation monitoring system for agitated critically ill patients Participants already taking multi-modal evaluation monitoring system as part of their regular medical care for agitated critically ill patients will compare their effectiveness for agitation for 3 years.
- Conditions
- Critically Ill Patients
- Being tested
- multi-model monitoring and alert
- Keywords
- Critically Ill, agitation, monitoring, remote
- Medical subject headings
- Critical Illness, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-model monitoring and alertDiagnostic test
All agitated critically illed patients are monitored by manual and multi-model monitoring and alert system
| Study group | Role | What they receive |
|---|---|---|
| control group: monitoring by manual way | Not described | |
| multiple-model monitoring group: agitation monitoring by remote video-radar wave | Not described Receives: Diagnostic Test: multi-model monitoring and alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correct rate for alerting agitated critically ill patients
Measured: 10-15 seconds every agitated patients during stay in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 May 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 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 PatientsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Quzhou, The Second Affiliated Hospital of Jiaxing University, Zhoushan Hospital of Zhejiang, Longquan People's Hospital, Fuyang District First People's Hospital of Hangzhou, The Third Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543602
- Sponsor's protocol ID
- 2024 0135
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-modal Recognition Model and Efficacy Evaluation for Agitation Behavior in Critically Ill Patients Based on Remote -Ultra-sensitive Detection Wave ---A Multi-center, Open-label, Observational Study
- ClinicalTrials.gov ID
- NCT06543602
- Acronym / sponsor ID
- 2024 0135
- Conditions
- Critically Ill Patients
- Keywords
- Critically Ill, agitation, monitoring, remote
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- People's Hospital of Quzhou, The Second Affiliated Hospital of Jiaxing University, Zhoushan Hospital of Zhejiang, Longquan People's Hospital, Fuyang District First People's Hospital of Hangzhou, The Third Affiliated Hospital of Wenzhou Medical University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Aug 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.
The goal of this observational study is to learn about the effectiveness of the multi-modal evaluation for agitation behavior in critically ill patients based on remote video-Ultra-sensitive detection wave.
The main question it aims to answer is: evaluate the effectiveness of multi-modal evaluation monitoring system for agitated critically ill patients Participants already taking multi-modal evaluation monitoring system as part of their regular medical care for agitated critically ill patients will compare their effectiveness for agitation for 3 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group: monitoring by manual way | – | – |
| multiple-model monitoring group: agitation monitoring by remote video-radar wave | – | Diagnostic Test: multi-model monitoring and alert |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patients with agitation
Key inclusion criteria (3 listed)
- Patients at risk of agitation in the ICU
- Patients with RASS score -2 and above
- ≦ 65 years old, ≧ 18 years old
Key exclusion criteria (11 listed)
- The affected party refused to participate in this study
- Missing/incomplete information
- Vulnerable groups such as pregnant women, those who lack the capacity for civil conduct and do not have the consent of their legal representatives
- Maxillofacial trauma, burns, tumors, surgery, etc. affect facial expression
- Patients with limb impairment and amputation
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 |
|---|---|---|
| multi-model monitoring and alertAll agitated critically illed patients are monitored by manual and multi-model monitoring and alert system | Diagnostic test | multiple-model monitoring group: agitation monitoring by remote video-radar wave |
Primary outcome
the correct rate for alerting agitated critically ill patients
Time frame: 10-15 seconds every agitated patients during stay in ICU
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 9 Aug 2024.
- 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.
the second affiliated hospital, Zhejiang University school of medicine
Hangzhou, China
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 Critically Ill Patients, 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 3 inclusion and 11 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 9 Aug 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correct rate for alerting agitated critically ill patients (time frame: 10-15 seconds every agitated patients during stay in ICU). 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 9 Aug 2024.