the Multi-modal Evaluation of Agitation in Critically Ill Patients Based on Remote Video-Ultra-sensitive Detection Wave

NCT06543602 | Recruiting DMC

• 1 other identifier: 2024 0135
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Critically Ill; agitation; monitoring; remote

Outcome Measures

Primary Outcomes (1)

• the correct rate for alerting agitated critically ill patients

  10-15 seconds every agitated patients during stay in ICU

Study Arms (2)

control group: monitoring by manual way

multiple-model monitoring group: agitation monitoring by remote video-radar wave

Diagnostic Test: multi-model monitoring and alert

Interventions

multi-model monitoring and alert DIAGNOSTIC_TEST

All agitated critically illed patients are monitored by manual and multi-model monitoring and alert system

multiple-model monitoring group: agitation monitoring by remote video-radar wave

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

any patients with agitation

You may qualify if:

• Patients at risk of agitation in the ICU
• Patients with RASS score -2 and above
• ≦ 65 years old, ≧ 18 years old

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• People's Hospital of Quzhou: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Zhoushan Hospital of Zhejiang: collaborator
• Longquan People's Hospital: collaborator
• Fuyang District First People's Hospital of Hangzhou: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (2)

the second affiliated hospital, Zhejiang University school of medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

SAHZU

Hanzhou, Zhejiang, 310009, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Critical Illness; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (2)