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

August 5, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Yongan Xu, PhD& MD
      • Hanzhou, Zhejiang, China, 310009
        • Active, not recruiting
        • SAHZU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

any patients with agitation

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group: monitoring by manual way
multiple-model monitoring group: agitation monitoring by remote video-radar wave
Diagnostic test: multi-model monitoring and alert
All agitated critically illed patients are monitored by manual and multi-model monitoring and alert system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the correct rate for alerting agitated critically ill patients
Time Frame: 10-15 seconds every agitated patients during stay in ICU
10-15 seconds every agitated patients during stay in ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

The Second Affiliated Hospital of Jiaxing University
People's Hospital of Quzhou
The Third Affiliated Hospital of Wenzhou Medical University
Longquan People's Hospital
Zhoushan Hospital of Zhejiang
Fuyang District First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024 0135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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