The Application of Point-of-care Ultrasonography in Differential Diagnosis of Shock in Emergency and Critical Care

August 16, 2022 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The adult, non-traumatic, non-DNR shock patients in the emergency room at NTUH are enrolled to our study. The point-of-care ultrasound in shock patients is performed by well-trained medical staffs.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The correlation between application of bedside ultrasound and differential diagnosis in shock patients
Time Frame: 6 month
The effect of bedside ultrasound on differential diagnosis and treatment of shock patients.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Min-Shan Tsai, PhD, National Taiwan University Medical College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202005121RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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