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

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

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

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

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