<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02995499</url>
  </required_header>
  <id_info>
    <org_study_id>405/16</org_study_id>
    <secondary_id>U1111-1190-9648</secondary_id>
    <nct_id>NCT02995499</nct_id>
  </id_info>
  <brief_title>Inter-rater Reliability of the ASA Classification</brief_title>
  <acronym>In-ASK</acronym>
  <official_title>Inter-rater Reliability of the ASA Classification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Clinic Frankfurt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Clinic Frankfurt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ASA-PS classification, a subjective classification system of the patients' preoperative&#xD;
      health status, contains a certain problem concerning its interrater reliability. A comparison&#xD;
      between anesthesiologic and surgical assessment of the preoperative patient condition has not&#xD;
      yet been extensively investigated. The aim of this study is to examine the latter in a&#xD;
      prospective, monocentric, observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Included will be prospectively all patients undergoing an operation under anesthesiologic&#xD;
      treatment in the one-period-time from the study-beginning at the Department of General and&#xD;
      Visceral Surgery of the University Clinic Frankfurt. The ASA-PS classification will be twice&#xD;
      conducted and documented during the informed consent process: once by the consulting surgeon&#xD;
      and once by the consulting anesthesiologist. The assigned class and the training status of&#xD;
      the involved physician are anonymously documented on the study case report form. The pre-,&#xD;
      peri- and postoperative patient data, in particular the demographic data (age, height,&#xD;
      weight, BMI), comorbidities, type and duration of operation, as well as perioperative&#xD;
      complications in a follow-up period of 90 days will be extracted from the electronic patient&#xD;
      record. The patient data documentation concludes with a contact and, if necessary,&#xD;
      examination of the patient (in hospital or by the family doctor) after the 90th postoperative&#xD;
      day. Subsequently two study cooperation partners, a senior surgeon and a senior&#xD;
      anesthesiologist, will assign a &quot;recommended&quot;-ASA-PS class to every pseudonymized patient&#xD;
      based only on the documented preoperative examination, demographics and comorbidities without&#xD;
      insight into the preoperative documented ASA-PS classifications or the postoperative course.&#xD;
&#xD;
      Primary Hypothesis:&#xD;
&#xD;
      The assessments of the preoperative state of health of general-surgical patients by means of&#xD;
      the ASA-PS classification carried out independently by members of different disciplines&#xD;
      result in a moderate interrater reliability of the latter.&#xD;
&#xD;
      Secondary Hypothesis:&#xD;
&#xD;
      The discrepancy between the abovementioned ASA-PS classification and that recommended by an&#xD;
      interdisciplinary committee decreases with increasing professional experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interrater reliability of the ASA classification</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Expressed as Krippendorff's alpha and as a Fleiss' kappa</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity rate</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>Clavien-Dindo-Klassifikation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>30 and 90 days postoperative</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">683</enrollment>
  <condition>ASA PS Klassifikation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing an operation under anesthesiologic treatment in the one-period-time&#xD;
        from the study-beginning at the Department of General and Visceral Surgery of the&#xD;
        University Clinic Frankfurt.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing an operation under anesthesiologic treatment in the&#xD;
             one-period-time from the study-beginning at the Department of General and Visceral&#xD;
             Surgery of the University Clinic Frankfurt.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ASA-Class 6.&#xD;
&#xD;
          -  Patients undergoing surgery more than twice in the same hospital stay (only two&#xD;
             evaluations per patient case admitted).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georgios Makridis, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Clinic Frankfurt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wolf Otto Bechstein, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>University Clinic Frankfurt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Clinic Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 12, 2022</last_update_submitted>
  <last_update_submitted_qc>February 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Clinic Frankfurt</investigator_affiliation>
    <investigator_full_name>Makridis Georgios</investigator_full_name>
    <investigator_title>Specialist for Visceral Surgery, Department of General and Visceral Surgery</investigator_title>
  </responsible_party>
  <keyword>ASA-PS classification</keyword>
  <keyword>inter-rater reliability</keyword>
  <keyword>general surgery</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995499
org study id: 405/16
secondary id: U1111-1190-9648
nct id: NCT02995499
lead sponsor: 
has dmc: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Interrater reliability of the ASA classification
time frame: through study completion, an average of 1 year
description: Expressed as Krippendorff's alpha and as a Fleiss' kappa
measure: Morbidity rate
time frame: 90 days postoperative
description: Clavien-Dindo-Klassifikation
measure: Mortality rate
time frame: 30 and 90 days postoperative
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Georgios Makridis, Dr. med.
role: Principal Investigator
affiliation: University Clinic Frankfurt
last name: Wolf Otto Bechstein, Prof. Dr.
role: Study Director
affiliation: University Clinic Frankfurt
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Clinic Frankfurt
investigator full name: Makridis Georgios
investigator title: Specialist for Visceral Surgery, Department of General and Visceral Surgery
sharing ipd: No