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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00776880
First Posted: October 21, 2008
Last Update Posted: December 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing Medical University
  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

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Time of recovery [ Time Frame: Six months after operation. ]

Secondary Outcome Measures:
  • Intraoperative consumption of drugs [ Time Frame: 1 day after operation ]
  • Incidence of side events [ Time Frame: 72 hours after operation ]
  • Hospitalization days [ Time Frame: From 0 min after operation to the time duration of discharge home, this measure would be varied in different patients ]
  • Psychological state [ Time Frame: Six months after operation ]
  • Life quality [ Time Frame: Six months after operation ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 20, 2008
First Posted: October 21, 2008
Last Update Posted: December 23, 2009
Last Verified: November 2009

Keywords provided by Nanjing Medical University:
Surgical operation