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

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ClinicalTrials.gov Identifier: NCT00776880
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:
Nanjing Medical University

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Elective Surgery Other: ASA scale Other: PPS scale

Study Design
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Study Type : Observational
Actual Enrollment : 1500 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00776880     History of Changes
Other Study ID Numbers: NMU-FY2008-MZ08
NJFY080921
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: November 2009

Keywords provided by Nanjing Medical University:
Surgical operation