UMIN-CTR Clinical Trial

Basic information
Public title	A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Acronym	A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Scientific Title	A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Scientific Title:Acronym	A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Region	Japan

Condition
Condition	Cardiopulmonary arrest on arrival
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the impact of COVID-19 pandemic on cardiopulmonary resuscitation in our emergency department.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of survival hospitalization and discharge rates for secondary cardiopulmonary resuscitation performed in the year of the outbreak and the year of the target outbreak of novel coronavirus infection
Key secondary outcomes	Comparison of the background of secondary cardiopulmonary resuscitation performed between the year of the novel coronavirus outbreak and the target year Comparison of the elapsed time of secondary cardiopulmonary resuscitation performed between the year of the outbreak and the target year of the novel coronavirus infection Time to hospital transport in emergency patients

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who visit our emergency room and meet all of the following criteria will be eligible. 1) Year of COVID-19 pandemic Patients with cardiopulmonary arrest at the time of admission who were transported to the emergency room between January 1, 2020 and March 31, 2021. 2) Comparison group January 1, 2015 to December 31, 2019 Cardiopulmonary arrest at the time of arrival at the hospital who were transported to the emergency room during the above period.
Key exclusion criteria	Cases in which consent was not obtained
Target sample size	1230

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Yamagami
Organization	Shonan Kamakura General Hospital
Division name	Department of Emergency Medicine
Zip code	247-0072
Address	1370-1 Okamoto, Kamakura city, Kanagawa
TEL	0467-46-1717
Email	defender8chan@yahoo.co.jp

Public contact
Name of contact person	1st name Ichiro Middle name Last name Sekine
Organization	Shonan Kamakura General Hospital
Division name	Department of Emergency Medicine
Zip code	247-0072
Address	1370-1 Okamoto, Kamakura city, Kanagawa
TEL	0467-46-1717
Homepage URL
Email	ichirosekine@yahoo.co.jp

Sponsor
Institute	Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Tokushukai Group Ethics Committee
Address	Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel	03-3263-4801
Email	mirai-ec1@mirai-iryo.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2021 Year 06 Month 25 Day
Date of IRB	2021 Year 08 Month 01 Day
Anticipated trial start date	2021 Year 06 Month 25 Day
Last follow-up date	2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Register the relevant patients as research subjects and obtain the following clinical information from the medical records at the time of registration. Background of the research subject: gender, date of birth, identification code of the research subject, height, weight Time of resuscitation: time of admission to the hospital, time of cessation of resuscitation, time of resumption of autologous heartbeat, and time of death confirmation Information on cardiopulmonary arrest: initial waveform, waveform at the time of admission to the hospital, presence or absence of cardiopulmonary arrest, presence or absence of bystander CPR, presence or absence of tracheal intubation, medications administered, presence or absence of defibrillation History of cardiopulmonary arrest

Management information
Registered date	2021 Year 06 Month 26 Day
Last modified on	2022 Year 01 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051011