Inter-rater Reliability of the ASA Classification

NCT ID: NCT02995499

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 683 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2022-08-31

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.

Conditions

ASA PS Klassifikation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Clinic Frankfurt

OTHER

Sponsor Role: lead

Responsible Party

Makridis Georgios

Specialist for Visceral Surgery, Department of General and Visceral Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Makridis, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Clinic Frankfurt

Wolf Otto Bechstein, Prof. Dr.

Role: STUDY_DIRECTOR

University Clinic Frankfurt

Locations

University Clinic Frankfurt

Frankfurt am Main, , Germany

Countries

Germany

Other Identifiers

U1111-1190-9648

Identifier Type: OTHER

Identifier Source: secondary_id

405/16

Identifier Type: -

Identifier Source: org_study_id