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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

Tracking Information
First Submitted Date October 20, 2008
First Posted Date October 21, 2008
Last Update Posted Date December 23, 2009
Study Start Date January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2009)
Time of recovery [ Time Frame: Six months after operation. ]
Original Primary Outcome Measures
 (submitted: October 20, 2008)
Time of recovery [ Time Frame: Since the end of the operation to six-month follow-up. ]
Change History
Current Secondary Outcome Measures
 (submitted: March 31, 2009)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: October 20, 2008)
  • Intraoperative consumption of drugs [ Time Frame: During the whole process of operation ]
  • Incidence of side events [ Time Frame: Since after the completion of the operation to 72-hour follow-up period ]
  • Hospitalization days [ Time Frame: Since after the operation to discharge home ]
  • Psychological state [ Time Frame: Since after the operation to the end of the study ]
  • Life quality [ Time Frame: Since after the operation to the end of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients undergoing surgical operations
Condition Elective Surgery
Intervention
  • Other: ASA scale
    ASA scale evaluation before operation
  • Other: PPS scale
    PPS scale evaluation before operation
Study Groups/Cohorts
  • 1
    Patients assessed with ASA physical status scale
    Intervention: Other: ASA scale
  • 2
    Patients assessed with PPS scale
    Intervention: Other: PPS scale
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 20, 2008)
1500
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00776880
Other Study ID Numbers NMU-FY2008-MZ08
NJFY080921
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party XiaoFeng Shen, Nanjing Medical University
Study Sponsor Nanjing Medical University
Collaborators Not Provided
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
PRS Account Nanjing Medical University
Verification Date November 2009