- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04148794
The Development and Evaluation of the Efficacy for Echo-assisted Advanced Life Support Advanced Life Support (eALS)
The Development and Evaluation of the Efficacy for Echo-assisted Advanced Life Support Advanced Life Support (eALS)
The investigators conduct this project for integrating the point-of care ultrasound skill (POCUS) in to the American Heart Association (AHA) Advanced Cardiopulmonary Life Support (ACLS) guidelines and other critical conditions. Through lecture, head-on practice and scenario simulations, junior physicians who are the participants would be more familiar with the practice of POCUS in the settings of resuscitation and on the critical condition patients. The investigators aimed to increased the success rate of resuscitation and improve the outcomes of critical condition patients.
The investigators also try to make a template of ultrasound education in the board of emergency medicine and critical care medicine.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Advanced life support (ALS) is an important training course for junior physicians to learn how to manage critical patients. Ultrasound is an indispensable and easily accessible tool in emergency departments and critical care settings. Current guidelines suggested that ultrasound could be an integral part of resuscitative medicine. However, structured training is needed for better efficacy of ultrasound use during clinical use. The aim of this project is to incorporate ultrasound into the ALS course, including common critical diseases, such as dyspnea, shock, major trauma and cardiac arrests. Junior physicians at the National Taiwan University Hospital will be enrolled in this study as participants. Through lectures and hand-on practice, the junior physicians could be familiar with managing critical patients with ultrasound assistance. This study will be lasted for two years. In the 1st year, the investigators will establish the echo-assisted ALS (eALS) training course, set up assessment modules and simulation scenarios. In the 2nd year, the investigators will provide the formal eALS training course for 4 to 6 times, analyze the data and establish on-line learning modules. In addition, the investigators will promote the eALS course to other hospitals and other countries.
This pioneer study can provide experience of eALS training course and contribute to current medical education. Moreover, it can improve decision-making process and quality of care of the participants. Furthermore, the integrated on-line learning programs can be used to lessen the maturation time of the participants and would provide them to other departments and hospitals to improve patients' care.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wan-Ching Lien, MD., PhD.
- Phone Number: 65637 +886-23123456
- Email: wangchinglien@ntu.edu.tw
Study Contact Backup
- Name: Chih-Heng Chang, MD.
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Chih-Heng Chang, MD.
- Email: herman90021@msn.com
-
Sub-Investigator:
- Chih-Heng Chang, MD.
-
Principal Investigator:
- Chien-Hua Huang, MD., PhD.
-
Principal Investigator:
- Pei-Chuan Huang, MD.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all physicians or health care providers who are not well-experienced in the board of any kind of ultrasound
Exclusion Criteria:
- nil
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants who join the class of eALS
|
Integrated point-of-care ultrasound skill in to the setting of resuscitation, and critical condition patients. Educate the participants to use these protocols and monitoring if there were improvement of patient's outcomes |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The improvement of performance of participant in the practicing of ultrasound
Time Frame: 32 weeks
|
Compare the pre-lecture written test and a post-lecture written test results.
There is also a hands-on examination after the lecture, to evaluate the participants skills, by using scoring sheets.
|
32 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac arrest patients ROSC rates
Time Frame: 32 weeks
|
The rate of return of spontaneous circulation of cardiac arrest patients before and after the lecture
|
32 weeks
|
|
Length of stay (hours) in the emergency department
Time Frame: up to 32 weeks
|
We proposed that the disposition of patient would be faster after the lecture.
We would try to compare the length of stay (hours) in the ED before and after the lecture
|
up to 32 weeks
|
|
diagnostic accuracy of the participants after training
Time Frame: 4 weeks
|
sensitivity and specificity for acute chest pain and dyspnea, comparing with the final diagnosis.
The final diagnosis was made by the retrospective chart review by the experts.
|
4 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Department of Emergency medicine, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201812023RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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