The Combined Usage of Clinical Physical Finding in Manage... | NCT06528119

Studies
The Combined Usage of Clinical Physical Finding in Management of COVID 19 Patients

NCT06528119

Sponsor

St. Martin De Porress Hospital

Status

Completed

Last Update Posted

Aug 1, 2024Actual

Enrollment

10,000Actual

Phase

Not provided

Conditions

COVID-19 Pandemic

Interventions

COVID 19 pandemic

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2020Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

Jul 20, 2024Actual

First Submitted Date

Jul 29, 2024

First Submission Date that Met QC Criteria

Jul 29, 2024

First Posted Date

Jul 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2024

Last Update Posted Date

Aug 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chia-hsi Chen, Physician of Emergency Medicine, St. Martin De Porress HospitalPrincipal Investigator

Lead Sponsor

St. Martin De Porress HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START (simple triage and rapid treatment, START), Modified Early Warning Score (MEWS), and quick Sequential Organ Failure Assessment (qSOFA) as tools for assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients. In response to the need for scarce manpower when a large number of emergency patients appear, a simple and easy-to-operate assessment method is adopted for mild patients, and artificial intelligence technology can be further used to assist in the assessment for early response and medication.

Detailed Description

Due to the development of the pandemic , the virus has constantly mutated, leading to a vast majority of mild cases. This has significantly increased the burden on medical personnel. The investigators are trying to find a way to track whether their clinical symptoms have worsened. At the same time, the investigators want to know the changes in patient symptoms in real-time through online monitoring This is a single-center retrospective study of a group of COVID-19 patients. Review their medical records, mainly based on hospital field records and existing physiological indicators of patients such as blood pressure, heart rate, respiratory rate, and consciousness status. The partients visited the hospital between March 2020 and September 2022. All patients were given physiological value indicators MEWS, qSOFA, and START for scoring and assess the clinical symptom deterioration of COVID-19 patients.

In this study, The investigators collect the physiological values of each patient and the data on the nursing records during hospitalization to judge whether the symptoms have worsened

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID 19 pandemic	Other	Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START, MEWS, and qSOFA in COVID-19 patients.(COVID 19 病患).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COVID 19 pandemic	Assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients.	March 2020 and September 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a group of hospitalized COVID 19 patients were treated in the hospital between March 2020 and Sep.2022

Exclusion Criteria: Exclude patients who lack information in their medical records and incomplete clinical data.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

COVID 19 patients were treated in the hospital between March 2020 and Sep.2022

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chia-Hsi Chen, MD	St. Martin De Porres Hospital,emergency medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Martin De Porres Hospital		Tainan		60069	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000096763	Pandemic Preparedness

Ancestor Terms

ID	Term
D004189	Disaster Planning
D004190	Disasters
D004777	Environment
D004778	Environment and Public Health

Browse Leaves

Not provided

Browse Branches

Not provided