ASA PS KlassifikationIn-ASKNCT02995499
Inter-rater Reliability of the ASA Classification
An observational study of ASA PS Klassifikation, run by University Clinic Frankfurt at 1 site in Germany.
Trial summary
The ASA-PS classification, a subjective classification system of the patients' preoperative health status, contains a certain problem concerning its interrater reliability. A comparison between anesthesiologic and surgical assessment of the preoperative patient condition has not yet been extensively investigated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ASA PS Klassifikation
- How many people
- 683 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt.
Who may be able to join
- All patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt.
Who cannot join
- Patients with ASA-Class 6.
- Patients undergoing surgery more than twice in the same hospital stay (only two evaluations per patient case admitted).
Trial locations and contacts
1 site in 1 country.
About this study
The ASA-PS classification, a subjective classification system of the patients' preoperative health status, contains a certain problem concerning its interrater reliability. A comparison between anesthesiologic and surgical assessment of the preoperative patient condition has not yet been extensively investigated. The aim of this study is to examine the latter in a prospective, monocentric, observational study.
Read the detailed description
Included will be prospectively all patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt. The ASA-PS classification will be twice conducted and documented during the informed consent process: once by the consulting surgeon and once by the consulting anesthesiologist. The assigned class and the training status of the involved physician are anonymously documented on the study case report form. The pre-, peri- and postoperative patient data, in particular the demographic data (age, height, weight, BMI), comorbidities, type and duration of operation, as well as perioperative complications in a follow-up period of 90 days will be extracted from the electronic patient record. The patient data documentation concludes with a contact and, if necessary, examination of the patient (in hospital or by the family doctor) after the 90th postoperative day. Subsequently two study cooperation partners, a senior surgeon and a senior anesthesiologist, will assign a "recommended"-ASA-PS class to every pseudonymized patient based only on the documented preoperative examination, demographics and comorbidities without insight into the preoperative documented ASA-PS classifications or the postoperative course.
Primary Hypothesis:
The assessments of the preoperative state of health of general-surgical patients by means of the ASA-PS classification carried out independently by members of different disciplines result in a moderate interrater reliability of the latter.
Secondary Hypothesis:
The discrepancy between the abovementioned ASA-PS classification and that recommended by an interdisciplinary committee decreases with increasing professional experience.
- Conditions
- ASA PS Klassifikation
- Keywords
- ASA-PS classification, inter-rater reliability, general surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrater reliability of the ASA classification
Expressed as Krippendorff's alpha and as a Fleiss' kappa
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Morbidity rate
Clavien-Dindo-Klassifikation
Measured: 90 days postoperative
Mortality rate
Measured: 30 and 90 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ASA PS KlassifikationStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 683 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makridis Georgios, University Clinic Frankfurt
- Investigators
- Georgios Makridis, Dr. med., Principal investigator, University Clinic FrankfurtWolf Otto Bechstein, Prof. Dr., Study director, University Clinic Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995499
- Sponsor's protocol ID
- 405/16
- Other IDs
- U1111-1190-9648
- Acronym
- In-ASK
- Status last verified
- Feb 2022
- First submitted
- 11 Dec 2016
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
El Youzouri H, Wagner A, Woeste G, Schnaudigel R, Makridis G, Zacharowski K, Helmer P, Meybohm P, Bechstein WO, Wiegering A, Herrmann E, Schreckenbach T. Mind the gap: a prospective observational study of interprofessional differences in ASA-PS assessments between surgeons and anaesthesiologists. BMC Anesthesiol. 2026 Feb 4;26(1):143. doi: 10.1186/s12871-026-03664-8.
PubMed 41634571
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-rater Reliability of the ASA Classification
- ClinicalTrials.gov ID
- NCT02995499
- Acronym / sponsor ID
- In-ASK / 405/16
- Conditions
- ASA PS Klassifikation
- Keywords
- ASA-PS classification, inter-rater reliability, general surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 683 participants (estimated)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Aug 2022 (estimated)
- First posted
- 16 Dec 2016 (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.
The ASA-PS classification, a subjective classification system of the patients' preoperative health status, contains a certain problem concerning its interrater reliability. A comparison between anesthesiologic and surgical assessment of the preoperative patient condition has not yet been extensively investigated. The aim of this study is to examine the latter in a prospective, monocentric, observational study.
Detailed description
Included will be prospectively all patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt. The ASA-PS classification will be twice conducted and documented during the informed consent process: once by the consulting surgeon and once by the consulting anesthesiologist. The assigned class and the training status of the involved physician are anonymously documented on the study case report form. The pre-, peri- and postoperative patient data, in particular the demographic data (age, height, weight, BMI), comorbidities, type and duration of operation, as well as perioperative complications in a follow-up period of 90 days will be extracted from the electronic patient record. The patient data documentation concludes with a contact and, if necessary, examination of the patient (in hospital or by the family doctor) after the 90th postoperative day. Subsequently two study cooperation partners, a senior surgeon and a senior anesthesiologist, will assign a "recommended"-ASA-PS class to every pseudonymized patient based only on the documented preoperative examination, demographics and comorbidities without insight into the preoperative documented ASA-PS classifications or the postoperative course.
Primary Hypothesis:
The assessments of the preoperative state of health of general-surgical patients by means of the ASA-PS classification carried out independently by members of different disciplines result in a moderate interrater reliability of the latter.
Secondary Hypothesis:
The discrepancy between the abovementioned ASA-PS classification and that recommended by an interdisciplinary committee decreases with increasing professional experience.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt.
Key inclusion criteria (1 listed)
- All patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt.
Key exclusion criteria (2 listed)
- Patients with ASA-Class 6.
- Patients undergoing surgery more than twice in the same hospital stay (only two evaluations per patient case admitted).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interrater reliability of the ASA classification
Time frame: through study completion, an average of 1 year
Expressed as Krippendorff's alpha and as a Fleiss' kappa
2 secondary outcomes
Morbidity rate
Time frame: 90 days postoperative
Mortality rate
Time frame: 30 and 90 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Derived from this study: PubMed 41634571El Youzouri H, Wagner A, Woeste G, Schnaudigel R, Makridis G, Zacharowski K, Helmer P, Meybohm P, Bechstein WO, Wiegering A, Herrmann E, Schreckenbach T. Mind the gap: a prospective observational study of interprofessional differences in ASA-PS assessments between surgeons and anaesthesiologists. BMC Anesthesiol. 2026 Feb 4;26(1):143. doi: 10.1186/s12871-026-03664-8.
- Individual participant dataSharing planned: No
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.
Georgios Makridis, Dr. med. principal investigator
University Clinic Frankfurt
Wolf Otto Bechstein, Prof. Dr. study director
University Clinic Frankfurt
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 ASA PS Klassifikation, run by University Clinic Frankfurt at 1 site in Germany.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. 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 Germany. 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?
Results are not available in the source record.
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?
Interrater reliability of the ASA classification (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995499, which also lists 1 linked publication.
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 15 Feb 2022.