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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04478045
Other study ID # 202005121RINB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date July 31, 2022

Study information

Verified date August 2021
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For the emergency physicians and critical care specialists, how to quickly recognize shock from diverse clinical features and immediately treat shock patients to prevent progression to irreversible organ dysfunction from initially reversible shock condition are important issues and challenges. In recent years, ultrasonography had been extensively used in clinical practice recently, and well-trained medical staffs can quickly and easily apply ultrasound to evaluate, examine, diagnose, and even treat the patients. The clinical application of point-of-care ultrasound can help the first-line physicians rapidly evaluate and diagnose the main symptoms and signs of the patients at bedside, and further initially stabilize and appropriately treat the patients subsequently. The aim of this program is to prospectively collection of the findings of point-of-care ultrasonography in shock patients at emergency room in NTUH. The clinical manifestations, and followed up the examinations, treatments, and prognosis will also be collected. The effect of bedside ultrasound on differential diagnosis and treatment of shock patients will be analyzed. The results of the current study can provide the base for further clinical trials and set up of shock team.


Description:

Shock is defined as cellular and tissue hypoxia due to either reduced oxygen delivery, increased oxygen consumption, inadequate oxygen utilization, or a combination of these processes. According to the etiology about how it causes a decrease in blood flow to the cells and tissue, there are four types of shock naming cardiogenic shock, hypovolemic shock, obstructive shock, and distributive shock, respectively. The evaluation and management of shock patients is an extremely difficult challenge for the emergency physicians and critical care specialists. How to diagnose, classify, stabilize, and treat the shock patients quickly and in time are the arduous tasks. For the emergency physicians and critical care specialists, how to quickly recognize shock from diverse clinical features and immediately treat shock patients to prevent progression to irreversible organ dysfunction from initially reversible shock condition are important issues and challenges. In recent years, ultrasound instruments have gradually developed with higher radiographic quality and lower cost. Ultrasonography had been extensively used in clinical practice recently, and well-trained medical staffs can quickly and easily apply ultrasound to evaluate, examine, diagnose, and even treat the patients. The clinical application of point-of-care ultrasound can help the firstline physicians rapidly evaluate and diagnose the main symptoms and signs of the patients at bedside, and further initially stabilize and appropriately treat the patients subsequently. The aim of this program is to prospectively collection of the findings of point-of-care ultrasonography in shock patients at emergency room in NTUH. The clinical manifestations, and followed up the examinations, treatments, and prognosis will also be collected. The effect of bedside ultrasound on differential diagnosis and treatment of shock patients will be analyzed. The results of the current study can provide the base for further clinical trials and set up of shock team.


Recruitment information / eligibility

Status Completed
Enrollment 278
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: The shock patients in the emergency room at NTUH with one of the following conditions: 1. A clinician evaluated patients were with insufficient or improper tissue 2. Patients' systolic blood pressure < 90mmHg or mean arterial pressure < 65mmHg 3. Patients' laboratory data showed lactic acid > 2.2 mmol/L Exclusion Criteria: 1. Age < 20 years 2. Pregnancy 3. Traumatic patients 4. Patients with DNR(Do Not Resuscitate) status

Study Design


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The correlation between application of bedside ultrasound and differential diagnosis in shock patients The effect of bedside ultrasound on differential diagnosis and treatment of shock patients. 6 month
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