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NCT Number: NCT06543602

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the second affiliated hospital, Zhejiang University school of medicine, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-model monitoring and alert

Diagnostic Test

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

Primary outcomes

  1. the correct rate for alerting agitated critically ill patients

    Time frame: 10-15 seconds every agitated patients during stay in ICU

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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