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UnknownNCT02995499

Inter-rater Reliability of the ASA Classification

Status
Unknown
Phase
Study type
Observational
Enrollment
683 (estimated)
Sponsor
University Clinic Frankfurt · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2016-12-01
Primary completion
2019-12-01
Completion
2022-08-01
First posted
2016-12-16
Last updated
2022-02-15

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02995499. Inclusion in this directory is not an endorsement.