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

Artifacts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814941
• Other study ID #: 19MMHIS017e
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patient undergo general or regional anesthesia

• elective surgery

Exclusion Criteria:

• emergency operation

Related Conditions & MeSH terms

• Artifacts
• Integrated Advanced Information Management Systems

Intervention

Other:
• paper-based anesthesia record
to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record
• electronic documents
to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record

Locations

Country	Name	City	State
Taiwan	MacKay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	deviating values	to calculate the number of values deviating from the predefined baseline value	intraoperative (from the beginning to the end of anesthesia record)
Secondary	percentage of devotional artifacts	to evaluate how many percentage of the deviations are artifacts	intraoperative (from the beginning to the end of anesthesia record)
Secondary	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)
Secondary	causes of artifacts	to find out the cause of the artifact and respective percentage	intraoperative (from the beginning to the end of anesthesia record)