UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Makoto Ozaki
Organization	Tokyo Women's Medical University
Division name	Department of Anesthesiology
Address	8-1 Kawadacho Shinjuku Tokyo
TEL	03-3353-8111
Email	mozaki@anes.twmu.ac.jp

Public contact
Name of contact person	Maho Kinoshita
Organization	Tokyo Women's Medical University
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019133