The Incidence of Artifacts in the Anesthesia Information Management System Database.

To Evaluate the Incidence of Artifacts in the Locally Developed AIMS Database.

The purpose of the study is to evaluate the incidence of artifacts in the developed AIMS database

Study Overview

• Status: Completed
• Conditions: Artifacts; Integrated Advanced Information Management Systems
• Intervention / Treatment: Other: paper-based anesthesia record; Other: electronic documents

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergo general or regional anesthesia for surgery

Description

Inclusion Criteria:

• patient undergo general or regional anesthesia
• elective surgery

Exclusion Criteria:

• emergency operation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
paper-based anesthesia record; 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.	Other: paper-based anesthesia record; to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record
electronic documents; 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.	Other: electronic documents; to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of artifacts	to evaluate how many percentage of artifacts for each of the included parameters	intraoperative (from the beginning to the end of anesthesia record)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
deviating values	to calculate the number of values deviating from the predefined baseline value	intraoperative (from the beginning to the end of anesthesia record)
percentage of devotional artifacts	to evaluate how many percentage of the deviations are artifacts	intraoperative (from the beginning to the end of anesthesia record)
episodes of artifacts	to find out the average of number of episodes across each artifact	intraoperative (from the beginning to the end of anesthesia record)
causes of artifacts	to find out the cause of the artifact and respective percentage	intraoperative (from the beginning to the end of anesthesia record)

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Artifacts; anesthesia information management system
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 19MMHIS017e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No