Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT04148794
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2019-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Development and Evaluation of the Efficacy for Echo-assisted Advanced Life Support Advanced Life Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-25', 'studyFirstSubmitDate': '2019-10-27', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiac arrest patients ROSC rates', 'timeFrame': '32 weeks', 'description': 'The rate of return of spontaneous circulation of cardiac arrest patients before and after the lecture'}, {'measure': 'Length of stay (hours) in the emergency department', 'timeFrame': 'up to 32 weeks', 'description': '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'}, {'measure': 'diagnostic accuracy of the participants after training', 'timeFrame': '4 weeks', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'The improvement of performance of participant in the practicing of ultrasound', 'timeFrame': '32 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced life support', 'ultrasound', 'point-of-care ultrasound', 'echo-assisted advanced life support'], 'conditions': ['Education of Ultrasound']}, 'descriptionModule': {'briefSummary': '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.\n\nThe investigators also try to make a template of ultrasound education in the board of emergency medicine and critical care medicine.', 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all physicians or health care providers who are not well-experienced in the board of any kind of ultrasound\n\nExclusion Criteria:\n\n* nil'}, 'identificationModule': {'nctId': 'NCT04148794', 'acronym': 'eALS', 'briefTitle': 'The Development and Evaluation of the Efficacy for Echo-assisted Advanced Life Support Advanced Life Support', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Development and Evaluation of the Efficacy for Echo-assisted Advanced Life Support Advanced Life Support (eALS)', 'orgStudyIdInfo': {'id': '201812023RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants who join the class of eALS', 'interventionNames': ['Behavioral: echo-assisted advanced life support']}], 'interventions': [{'name': 'echo-assisted advanced life support', 'type': 'BEHAVIORAL', 'description': "Integrated point-of-care ultrasound skill in to the setting of resuscitation, and critical condition patients.\n\nEducate the participants to use these protocols and monitoring if there were improvement of patient's outcomes", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wan-Ching Lien, MD., PhD', 'role': 'CONTACT', 'email': 'wanchinglien@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '65637'}, {'name': 'Chih-Heng Chang, MD.', 'role': 'CONTACT', 'email': 'herman90021@msn.com'}, {'name': 'Chih-Heng Chang, MD.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chien-Hua Huang, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pei-Chuan Huang, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Wan-Ching Lien, MD., PhD.', 'role': 'CONTACT', 'email': 'wangchinglien@ntu.edu.tw', 'phone': '+886-23123456', 'phoneExt': '65637'}, {'name': 'Chih-Heng Chang, MD.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Department of Emergency medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}