- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00776880
Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment (ASAINPA)
December 22, 2009 updated by: Nanjing Medical University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Health Care Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients undergoing surgical operations
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Patients assessed with ASA physical status scale
|
ASA scale evaluation before operation
|
|
2
Patients assessed with PPS scale
|
PPS scale evaluation before operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time of recovery
Time Frame: Six months after operation.
|
Six months after operation.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intraoperative consumption of drugs
Time Frame: 1 day after operation
|
1 day after operation
|
|
Incidence of side events
Time Frame: 72 hours after operation
|
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
|
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
|
Six months after operation
|
|
Life quality
Time Frame: Six months after operation
|
Six months after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
October 20, 2008
First Submitted That Met QC Criteria
October 20, 2008
First Posted (Estimate)
October 21, 2008
Study Record Updates
Last Update Posted (Estimate)
December 23, 2009
Last Update Submitted That Met QC Criteria
December 22, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NMU-FY2008-MZ08
- NJFY080921
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.