NCT03814941

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

January 21, 2019

Last Update Submit

March 13, 2023

Conditions

Keywords

Artifactsanesthesia information management system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • deviating values

    intraoperative (from the beginning to the end of anesthesia record)

  • percentage of devotional artifacts

    intraoperative (from the beginning to the end of anesthesia record)

  • episodes of artifacts

    intraoperative (from the beginning to the end of anesthesia record)

  • causes of artifacts

    intraoperative (from the beginning to the end of anesthesia record)

Study Arms (2)

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

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

Interventions

to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record

paper-based anesthesia record

to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record

electronic documents

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergo general or regional anesthesia for surgery

You may qualify if:

  • patient undergo general or regional anesthesia
  • elective surgery

You may not qualify if:

  • emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacKay Memorial Hospital

Taipei, 104, Taiwan

Location

Related Publications (3)

  • 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: 30153918BACKGROUND
  • 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: 22806063BACKGROUND
  • 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: 28968279BACKGROUND

Study Officials

  • Chien-Chung Huang, MD

    Mackay Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Official Title: Principal Investigator,Attending physician of anesthesiology

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 24, 2019

Study Start

May 1, 2021

Primary Completion

July 1, 2022

Study Completion

December 31, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations