- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05584098
MEWS, qSOFA and Physiological Parameters Combination in the Emergency Room (qSOFA)
Modified Early Warning Score (MEWS), Quick Sequential Organ Failure Assessment (qSOFA) and Physiological Parameters Combination to Predict the Occurrence of Sepsis in the Emergency Room
In the development of sepsis treatment of recent years, the demand for medical manpower has increased significantly when patients with sepsis appear because of the expansion of medical care demand and shortened response time related to sepsis Due to the shortage of manpower, a more simple and easy-to-operate inspection method is adopted and artificial intelligence technology is used to assist in the evaluation.
The applicability of physiological indicators MEWS, qSOFA and physiological parameters combination as sepsis screening tools in emergency department (ED) and predicting sepsis outcome in the emergency department. When patients with sepsis appear, artificial intelligence technology is used to remind the physicians to respond and administer drugs as soon as possible.
This is a single-center retrospective study of a group of patients admitted to the emergency department. The medical records were reviewed, mainly based on the hospital site records and the existing vital signs of the patients. Attended a hospital emergency room between January 2020 and December 2022. Physiological numerical indicators MEWS and qSOFA were all scored to understand the distribution of sepsis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- A single-center retrospective study of a cohort of patients admitted to the emergency department
- To see a doctor in the emergency department of the hospital between January 2020 and December 2022, review their medical records, and focus on the hospital's on-site records and the existing patient's vital signs.
- The physiological indicators MEWS and qSOFA were scored to understand the distribution of sepsis.
- Remind the doctor when a suspected sepsis patient appears under level 5 triage and use artificial intelligence technology to assist
- This study will explore the specific improvement practices and effects of improving the response of patients with sepsis when they see a doctor
- To analyze and evaluate the economics and benefits of this operation mode, improve the accuracy of emergency inspection of sepsis patients and improve the rationality of hospital manpower deployment
- Scheduled progress of the plan: Patients who visited the emergency department of the hospital between January 2020 and December 2022 were included in this study under investigation. This is a retrospective study, and patients are required to undergo necessary examinations according to their own conditions, without any interference from the study
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Chiayi City, Taiwan, 600046
- St. Martin De Porres Hospital
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Chiayi City, Taiwan, 60069
- St. Martin De Porres Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- This is a single-center retrospective study of a group of patients admitted to the emergency department.
Exclusion Criteria:
- Patients with incomplete treatment clinical data, lack of information in medical records, trauma patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: qSOFA, MEWS and physiological parameters combination
Modified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA) and physiological parameters combination are used in prediction of occurrence of sepsis
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qSOFA ,MEWS and physiological parameters combination used in emergency medicine department could be helpful in the identification of the occurrence of sepsis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
qSOFA used in emergency medicine department
Time Frame: From date of randomization until the date of first documented progression assessed up to 36 months
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The qSOFA score is a simple score consisting of three items: respiratory rate (RR) ≥ 22 breaths per minute, altered mentation (Glasgow Coma Scale [GCS] < 15), and systolic blood pressure (SBP) < 100 mmHg and lowest score is 1 and highest is 3. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended |
From date of randomization until the date of first documented progression assessed up to 36 months
|
|
Modified Early Warning Score(MEWS) which quickly determine whether a particular patient needs increased medical attention
Time Frame: From date of randomization until the date of first documented progression assessed up to 36 months
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MEWS score = Systolic blood pressure + Heart rate + Urine output + Respiratory rate + Temperature + AVPU. The lowest score is 0 and highest score is 14. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended |
From date of randomization until the date of first documented progression assessed up to 36 months
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physiological parameters combination
Time Frame: From date of randomization until the date of first documented progression assessed up to 36 months
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Shock Index (SI) = Heart Rate / Systolic Blood Pressure Age-Adjusted Shock Index (Age SI) = Age x Shock Index Respiratory-Adjusted Shock Index (RASI) = HR/SBP × (RR/10)
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From date of randomization until the date of first documented progression assessed up to 36 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chia-Hsi Chen, MD, Emergency Medicine Department of St. Martin De Porres Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21B-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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