UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016990 |
|---|---|
| Receipt number | 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 23:25:26 |
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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
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
sevopropo@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019133
