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Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) in the Emergency Room (qSOFA)

Primary Purpose

Sepsis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
qSOFA and MEWS
Sponsored by
St. Martin De Porress Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sepsis focused on measuring Sepsis, Modified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA), emergency Medicine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Martin De Porres HospitalRecruiting
  • St. Martin De Porres HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

qSOFA and MEWS

Arm Description

Modified Early Warning Score(MEWS) and quick Sequential Organ Failure Assessment(qSOFA) are used in prediction of occurrence of sepsis

Outcomes

Primary Outcome Measures

qSOFA used in emergency medicine department
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
Modified Early Warning Score(MEWS) which quickly determine whether a particular patient needs increased medical attention
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

Secondary Outcome Measures

Full Information

First Posted
October 7, 2022
Last Updated
June 14, 2023
Sponsor
St. Martin De Porress Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05584098
Brief Title
Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) in the Emergency Room
Acronym
qSOFA
Official Title
Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) to Predict the Occurrence of Sepsis in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
June 10, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Martin De Porress Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 and qSOFA 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Sepsis, Modified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA), emergency Medicine

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time.
Masking
None (Open Label)
Masking Description
Mask all identified labels in all raw data
Allocation
N/A
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
qSOFA and MEWS
Arm Type
Other
Arm Description
Modified Early Warning Score(MEWS) and quick Sequential Organ Failure Assessment(qSOFA) are used in prediction of occurrence of sepsis
Intervention Type
Other
Intervention Name(s)
qSOFA and MEWS
Intervention Description
qSOFA and MEWS used in emergency medicine department could be helpful in the identification of the occurrence of sepsis
Primary Outcome Measure Information:
Title
qSOFA used in emergency medicine department
Description
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
Time Frame
From date of randomization until the date of first documented progression assessed up to 36 months
Title
Modified Early Warning Score(MEWS) which quickly determine whether a particular patient needs increased medical attention
Description
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
Time Frame
From date of randomization until the date of first documented progression assessed up to 36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Hsi Chen, MD
Phone
886-5-2756000
Ext
37078
Email
medicine@stm.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hsi Chen, MD
Organizational Affiliation
Emergency Medicine Department of St. Martin De Porres Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Martin De Porres Hospital
City
Chiayi City
ZIP/Postal Code
600046
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
卜誠
Phone
886-5-2756000
Ext
3708
Email
stmirb@stm.org.tw
Facility Name
St. Martin De Porres Hospital
City
Chiayi City
ZIP/Postal Code
60069
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Chia-Hsi, MD
Phone
886-5-275600
Ext
3708
Email
urologist3509@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data (IPD) is not available to other researchers

Learn more about this trial

Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) in the Emergency Room

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