Clinical trial NCT02995499: Inter-rater Reliability of the ASA Classification
Official title: Inter-rater Reliability of the ASA Classification
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ASA PS Klassifikation
Keywords: ASA-PS classification
inter-rater reliability
general surgery
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with ASA-Class 6.
* Patients undergoing surgery more than twice in the same hospital stay (only two evaluations per patient case admitted).

Primary outcomes:
measure: Interrater reliability of the ASA classification
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Morbidity rate
timeFrame: 90 days postoperative
measure: Mortality rate
timeFrame: 30 and 90 days postoperative
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Clinic Frankfurt
Study officials:
affiliation: University Clinic Frankfurt
name: Georgios Makridis, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinic Frankfurt
name: Wolf Otto Bechstein, Prof. Dr.
role: STUDY_DIRECTOR
References: