Elective SurgeryASAINPANCT00776880
Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment
An observational study of Elective Surgery, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elective Surgery
- What is being tested?
- ASA scale and PPS scale
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgical operations
Who may be able to join
- Patients undergoing elective surgical operation
- Age from 18-65 years
Who cannot join
- Age < 18 years or > 65 years
- Not willing to participate in this study
- Patients from emergency department
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
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
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.
- Conditions
- Elective Surgery
- Being tested
- ASA scale, PPS scale
- Keywords
- Surgical operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASA scaleOther
ASA scale evaluation before operation
PPS scaleOther
PPS scale evaluation before operation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients assessed with ASA physical status scale Receives: Other: ASA scale | |
| 2 | Patients assessed with PPS scale Receives: Other: PPS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of recovery
Measured: Six months after operation.
Secondary outcomes (5)
Intraoperative consumption of drugs
Measured: 1 day after operation
Incidence of side events
Measured: 72 hours after operation
Hospitalization days
Measured: From 0 min after operation to the time duration of discharge home, this measure would be varied in different patients
Psychological state
Measured: Six months after operation
Life quality
Measured: Six months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776880
- Sponsor's protocol ID
- NMU-FY2008-MZ08
- Other IDs
- NJFY080921
- Acronym
- ASAINPA
- Status last verified
- Nov 2009
- First submitted
- 20 Oct 2008
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00776880
- Acronym / sponsor ID
- ASAINPA / NMU-FY2008-MZ08
- Conditions
- Elective Surgery
- Keywords
- Surgical operation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: ASA scalePatients assessed with ASA physical status scale |
| 2 | – | Other: PPS scalePatients assessed with PPS scale |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgical operations
Key inclusion criteria (2 listed)
- Patients undergoing elective surgical operation
- Age from 18-65 years
Key exclusion criteria (3 listed)
- Age < 18 years or > 65 years
- Not willing to participate in this study
- Patients from emergency department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASA scaleASA scale evaluation before operation | Other | 1 |
| PPS scalePPS scale evaluation before operation | Other | 2 |
Primary outcome
Time of recovery
Time frame: Six months after operation.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Surgery, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of recovery (time frame: Six months after operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2009.