Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment (ASAINPA)

This study has been completed.

Sponsor:

Information provided by:

Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT00776880

First received: October 20, 2008

Last updated: December 22, 2009

Last verified: November 2009

History of Changes

Purpose

American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for assessing the status of patients before operation. However, merely the value of ASA scale did not give enough information of patients to determine their prognosis and improvement of outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. Therefore, the investigators hypothesized that the ASA scale only was needed to be modified and should be replaced by a comprehensive gauge to evaluate the status of patients in depth. Based on this thought, the investigators used a new system, i.e., physical-psycho-social (PPS) scale, to assess the overall state before surgical procedures.

Condition	Intervention
Elective Surgery	Other: ASA scale Other: PPS scale


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Reevaluating the American Society of Anesthesiologists (ASA) Physical Status System in Patients Assessment and Compared With a New Scale of Physical-psycho-social Gauge Raised by Our Institution

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

Time of recovery [ Time Frame: Six months after operation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intraoperative consumption of drugs [ Time Frame: 1 day after operation ] [ Designated as safety issue: Yes ]
Incidence of side events [ Time Frame: 72 hours after operation ] [ Designated as safety issue: Yes ]
Hospitalization days [ Time Frame: From 0 min after operation to the time duration of discharge home, this measure would be varied in different patients ] [ Designated as safety issue: No ]
Psychological state [ Time Frame: Six months after operation ] [ Designated as safety issue: Yes ]
Life quality [ Time Frame: Six months after operation ] [ Designated as safety issue: No ]


Enrollment:	1500
Study Start Date:	January 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients assessed with ASA physical status scale	Other: ASA scale ASA scale evaluation before operation
2 Patients assessed with PPS scale	Other: PPS scale PPS scale evaluation before operation

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All patients undergoing surgical operations

Criteria

Inclusion Criteria:

Patients undergoing elective surgical operation
Age from 18-65 years

Exclusion Criteria:

Age < 18 years or > 65 years
Not willing to participate in this study
Patients from emergency department

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00776880

Locations


China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004

Sponsors and Collaborators

Nanjing Medical University

Investigators


Study Chair:	XiaoFeng Shen, MD	Nanjing Medical University

More Information


Responsible Party:	XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00776880 History of Changes
Other Study ID Numbers:	NMU-FY2008-MZ08 NJFY080921
Study First Received:	October 20, 2008
Last Updated:	December 22, 2009
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:


Surgical operation

ClinicalTrials.gov processed this record on September 26, 2016

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