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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016990
Receipt No. R000019133
Scientific Title Validation for the utility of the Surgical Apgar Score and American Society of Anesthesiologists Physical Status Classification to predict the outcome of postoperative patients. Retrospective Study
Date of disclosure of the study information 2015/04/01
Last modified on 2017/04/01

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Basic information
Public title Validation for the utility of the Surgical Apgar Score and American Society of Anesthesiologists Physical Status Classification to predict the outcome of postoperative patients. Retrospective Study
Acronym Validation for the utility of the Surgical Apgar Score and ASA-PS to predict the outcome of postoperative patients. Retrospective Study
Scientific Title Validation for the utility of the Surgical Apgar Score and American Society of Anesthesiologists Physical Status Classification to predict the outcome of postoperative patients. Retrospective Study
Scientific Title:Acronym Validation for the utility of the Surgical Apgar Score and ASA-PS to predict the outcome of postoperative patients. Retrospective Study
Region
Japan

Condition
Condition Surgical disease
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 There had never been such a routine, objective, simple evaluation of patient after surgery to inform postoperative risks that we surgical team had relied mainly on subjective assessment. In 2007, Surgical Apgar Score which is a simple 10 point scoring system based on 3 easily obtained intraoperative parameters, the estimated intraoperative blood loss, the lowest mean arterial pressure and the lowest heart rate, was developed to satisfy those purposes.
Since this advent, some authors has reported the utility and validity of this scoring system to wide range of subspecialties however especially in Japan there has never been such a report on a large scale. To confirm the validity of Surgical Apgar Score in Japanese environments, we assessed the utility of this score, using surgical cases in our institution which include a wide range of procedures. And we assessed the utility of ASA-PS and new score we proposed in this study for predicting 30-days mortality after surgery.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 7days and 30days and 60days postoperative mortality.
Key secondary outcomes ACU of the ASA physical status.
AUC of the Surgical Apgar Score.

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
17 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Surgical patients in Tokyo Women's Medical University Hospital from February 1, 2008 to February 29, 2012.
Key exclusion criteria The patients aged under 16.
The patients of cardiac surgery, major vascular surgery, MRI guided neurosurgery.
Target sample size 23304

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ozaki
Organization Tokyo Women's Medical University
Division name Department of Anesthesiology
Zip code
Address 8-1 Kawadacho Shinjuku Tokyo
TEL 03-3353-8111
Email mozaki@anes.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Maho Kinoshita
Organization Tokyo Women's Medical University
Division name Department of Anesthesiology
Zip code
Address 8-1 Kawadacho Shinjuku Tokyo
TEL 03-3353-8111
Homepage URL
Email sevopropo@yahoo.co.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University, Department of Anesthesiology
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
Address
Tel
Email

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
2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The utility of the Surgical apgar score and ASA physical status was validated.

Retrospective study.

Management information
Registered date
2015 Year 03 Month 31 Day
Last modified on
2017 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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