<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/NCT03814941</url>
  </required_header>
  <id_info>
    <org_study_id>19MMHIS017e</org_study_id>
    <nct_id>NCT03814941</nct_id>
  </id_info>
  <brief_title>The Incidence of Artifacts in the Anesthesia Information Management System Database.</brief_title>
  <official_title>To Evaluate the Incidence of Artifacts in the Locally Developed AIMS Database.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mackay Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the incidence of artifacts in the developed AIMS&#xD;
      database&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At first, the authors evaluated the accuracy of the traditional, manually completed&#xD;
      paper-based documentation, which sets a benchmark for the accuracy that the electronic&#xD;
      documentation and database provides.&#xD;
&#xD;
      At the second portion, the investigators used the paper-based documentation as a standard to&#xD;
      compare the electronic documentation. The incidence of artifact was double checked by two&#xD;
      investigators.&#xD;
&#xD;
      At the third portion, the authors calculated the artifact incidence in the AIMS database,&#xD;
      using paper based and electric document anesthesia records as the standard respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2021</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of artifacts</measure>
    <time_frame>intraoperative (from the beginning to the end of anesthesia record)</time_frame>
    <description>to evaluate how many percentage of artifacts for each of the included parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>deviating values</measure>
    <time_frame>intraoperative (from the beginning to the end of anesthesia record)</time_frame>
    <description>to calculate the number of values deviating from the predefined baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of devotional artifacts</measure>
    <time_frame>intraoperative (from the beginning to the end of anesthesia record)</time_frame>
    <description>to evaluate how many percentage of the deviations are artifacts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>episodes of artifacts</measure>
    <time_frame>intraoperative (from the beginning to the end of anesthesia record)</time_frame>
    <description>to find out the average of number of episodes across each artifact</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>causes of artifacts</measure>
    <time_frame>intraoperative (from the beginning to the end of anesthesia record)</time_frame>
    <description>to find out the cause of the artifact and respective percentage</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Artifacts</condition>
  <condition>Integrated Advanced Information Management Systems</condition>
  <arm_group>
    <arm_group_label>paper-based anesthesia record</arm_group_label>
    <description>The AIMS sampled the vital signs from the monitor every minute and stored in the database.&#xD;
The incidence of artifacts in the AIMS database was evaluated by paper-based documented anesthesia record.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>electronic documents</arm_group_label>
    <description>The AIMS sampled the vital signs from the monitor every minute and stored in the database.&#xD;
The incidence of artifacts in the AIMS database was evaluated by electric documented anesthesia record.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>paper-based anesthesia record</intervention_name>
    <description>to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record</description>
    <arm_group_label>paper-based anesthesia record</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electronic documents</intervention_name>
    <description>to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record</description>
    <arm_group_label>electronic documents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergo general or regional anesthesia for surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient undergo general or regional anesthesia&#xD;
&#xD;
          -  elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Chung Huang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mackay Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MacKay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>104</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Wilbanks BA, Berner ES, Alexander GL, Azuero A, Patrician PA, Moss JA. The effect of data-entry template design and anesthesia provider workload on documentation accuracy, documentation efficiency, and user-satisfaction. Int J Med Inform. 2018 Oct;118:29-35. doi: 10.1016/j.ijmedinf.2018.07.006. Epub 2018 Jul 24.</citation>
    <PMID>30153918</PMID>
  </reference>
  <reference>
    <citation>Kool NP, van Waes JA, Bijker JB, Peelen LM, van Wolfswinkel L, de Graaff JC, van Klei WA. Artifacts in research data obtained from an anesthesia information and management system. Can J Anaesth. 2012 Sep;59(9):833-41. doi: 10.1007/s12630-012-9754-0. Epub 2012 Jul 18.</citation>
    <PMID>22806063</PMID>
  </reference>
  <reference>
    <citation>Hoorweg AJ, Pasma W, van Wolfswinkel L, de Graaff JC. Incidence of Artifacts and Deviating Values in Research Data Obtained from an Anesthesia Information Management System in Children. Anesthesiology. 2018 Feb;128(2):293-304. doi: 10.1097/ALN.0000000000001895.</citation>
    <PMID>28968279</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chien-Chung,Huang</investigator_full_name>
    <investigator_title>Official Title: Principal Investigator,Attending physician of anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Artifacts</keyword>
  <keyword>anesthesia information management system</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <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/NCT03814941
org study id: 19MMHIS017e
nct id: NCT03814941
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the incidence of artifacts in the developed AIMS
      database
At first, the authors evaluated the accuracy of the traditional, manually completed
      paper-based documentation, which sets a benchmark for the accuracy that the electronic
      documentation and database provides.

      At the second portion, the investigators used the paper-based documentation as a standard to
      compare the electronic documentation. The incidence of artifact was double checked by two
      investigators.

      At the third portion, the authors calculated the artifact incidence in the AIMS database,
      using paper based and electric document anesthesia records as the standard respectively.
observational model: Cohort
time perspective: Retrospective
measure: percentage of artifacts
time frame: intraoperative (from the beginning to the end of anesthesia record)
description: to evaluate how many percentage of artifacts for each of the included parameters
measure: deviating values
time frame: intraoperative (from the beginning to the end of anesthesia record)
description: to calculate the number of values deviating from the predefined baseline value
measure: percentage of devotional artifacts
time frame: intraoperative (from the beginning to the end of anesthesia record)
description: to evaluate how many percentage of the deviations are artifacts
measure: episodes of artifacts
time frame: intraoperative (from the beginning to the end of anesthesia record)
description: to find out the average of number of episodes across each artifact
measure: causes of artifacts
time frame: intraoperative (from the beginning to the end of anesthesia record)
description: to find out the cause of the artifact and respective percentage
arm group label: paper-based anesthesia record
description: The AIMS sampled the vital signs from the monitor every minute and stored in the database.
The incidence of artifacts in the AIMS database was evaluated by paper-based documented anesthesia record.
arm group label: electronic documents
description: The AIMS sampled the vital signs from the monitor every minute and stored in the database.
The incidence of artifacts in the AIMS database was evaluated by electric documented anesthesia record.
intervention type: Other
intervention name: paper-based anesthesia record
description: to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record
arm group label: paper-based anesthesia record
intervention type: Other
intervention name: electronic documents
description: to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record
arm group label: electronic documents
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chien-Chung Huang, MD
role: Study Director
affiliation: Mackay Memorial Hospital
facility: 
country: Taiwan
citation: Wilbanks BA, Berner ES, Alexander GL, Azuero A, Patrician PA, Moss JA. The effect of data-entry template design and anesthesia provider workload on documentation accuracy, documentation efficiency, and user-satisfaction. Int J Med Inform. 2018 Oct;118:29-35. doi: 10.1016/j.ijmedinf.2018.07.006. Epub 2018 Jul 24.
PMID: 30153918
citation: Kool NP, van Waes JA, Bijker JB, Peelen LM, van Wolfswinkel L, de Graaff JC, van Klei WA. Artifacts in research data obtained from an anesthesia information and management system. Can J Anaesth. 2012 Sep;59(9):833-41. doi: 10.1007/s12630-012-9754-0. Epub 2012 Jul 18.
PMID: 22806063
citation: Hoorweg AJ, Pasma W, van Wolfswinkel L, de Graaff JC. Incidence of Artifacts and Deviating Values in Research Data Obtained from an Anesthesia Information Management System in Children. Anesthesiology. 2018 Feb;128(2):293-304. doi: 10.1097/ALN.0000000000001895.
PMID: 28968279
responsible party type: Principal Investigator
investigator affiliation: Mackay Memorial Hospital
investigator full name: Chien-Chung,Huang
investigator title: Official Title: Principal Investigator,Attending physician of anesthesiology
mesh term: Anesthetics
sharing ipd: No