UMIN-CTR Clinical Trial

Basic information
Public title	Cardiac arrest during anesthesia: a 20-year retrospective observational study in a tertiary care university hospital
Acronym	Cardiac arrest during anesthesia
Scientific Title	Cardiac arrest during anesthesia: a 20-year retrospective observational study in a tertiary care university hospital
Scientific Title:Acronym	Cardiac arrest during anesthesia
Region	Japan

Condition
Condition	patients under anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigated the cardiac arrest during anesthesia to reveal the risk factors of cardiac arrest.
Basic objectives2	Others
Basic objectives -Others	To reveal the risk factors of failure to achieve return of spontaneous circulation
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The incident rate of cardiac arrest during anesthesia
Key secondary outcomes	The causes of cardiac arrest during anesthesia

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 with cardiac arrest during anesthesia
Key exclusion criteria	Patients with cardiac arrest before anesthesia induction
Target sample size	100000

Research contact person
Name of lead principal investigator	1st name Naoyuki Middle name Last name Hirata
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Zip code	060-8543
Address	291, S1, W16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Email	naohirata@mac.com

Public contact
Name of contact person	1st name Naoyuki Middle name Last name Hirata
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Zip code	060-8543
Address	291, S1, W16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	naohirata@mac.com

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Sapporo Medical University
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	Sapporo Medical University School of Medicine
Address	291, S1, W16, Chuo-ku, Sapporo
Tel	011-611-2111
Email	naohirata@mac.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 06 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s00540-021-03034-3
Number of participants that the trial has enrolled	11851
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 01 Month 10 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 01 Month 21 Day
Date of IRB	2021 Year 01 Month 21 Day
Anticipated trial start date	2021 Year 01 Month 21 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2021 Year 06 Month 26 Day
Last modified on	2022 Year 02 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051013