ShockNCT04478045
The Application of Point-of-care Ultrasonography in Differential Diagnosis of Shock in Emergency and Critical Care
An observational study of Shock and Ultrasonography, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Shock, Ultrasonography, Differential Diagnosis
- How many people
- 278 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The shock patients in the emergency room at NTUH with one of the following conditions:
- A clinician evaluated patients were with insufficient or improper tissue
- Patients' systolic blood pressure < 90mmHg or mean arterial pressure < 65mmHg
- Patients' laboratory data showed lactic acid > 2.2 mmol/L
Who cannot join
- Age < 20 years
- Pregnancy
- Traumatic patients
- Patients with DNR(Do Not Resuscitate) status
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Shock, Ultrasonography, Differential Diagnosis, Emergencies, Critical Care
- Keywords
- Shock, Ultrasonography, Differential diagnosis, Emergency care, Critical care
- Medical subject headings
- Shock, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Aug 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min-Shan Tsai, PhD, Study director, National Taiwan University Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478045
- Sponsor's protocol ID
- 202005121RINB
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Point-of-care Ultrasonography in Differential Diagnosis of Shock in Emergency and Critical Care
- ClinicalTrials.gov ID
- NCT04478045
- Acronym / sponsor ID
- 202005121RINB
- Conditions
- Shock, Ultrasonography, Differential Diagnosis, Emergencies, Critical Care
- Keywords
- Shock, Ultrasonography, Differential diagnosis, Emergency care, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- A clinician evaluated patients were with insufficient or improper tissue
- Patients' systolic blood pressure < 90mmHg or mean arterial pressure < 65mmHg
- Patients' laboratory data showed lactic acid > 2.2 mmol/L
Key exclusion criteria (4 listed)
- Age < 20 years
- Pregnancy
- Traumatic patients
- Patients with DNR(Do Not Resuscitate) status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Shan Tsai, PhD study director
National Taiwan University Medical College and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Ultrasonography, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between application of bedside ultrasound and differential diagnosis in shock patients (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.