ArtifactsNCT03814941
The Incidence of Artifacts in the Anesthesia Information Management System Database.
An observational study of Artifacts and Integrated Advanced Information Management Systems, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of the study is to evaluate the incidence of artifacts in the developed AIMS database Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Artifacts, Integrated Advanced Information Management Systems
- What is being tested?
- paper-based anesthesia record and electronic documents
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergo general or regional anesthesia for surgery
Who may be able to join
- patient undergo general or regional anesthesia
- elective surgery
Who cannot join
- emergency operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- paper-based anesthesia record, electronic documents
- Keywords
- Artifacts, anesthesia information management system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paper-based anesthesia recordOther
to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record
electronic documentsOther
to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: electronic documents |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of artifacts
to evaluate how many percentage of artifacts for each of the included parameters
Measured: intraoperative (from the beginning to the end of anesthesia record)
Secondary outcomes (4)
deviating values
to calculate the number of values deviating from the predefined baseline value
Measured: intraoperative (from the beginning to the end of anesthesia record)
percentage of devotional artifacts
to evaluate how many percentage of the deviations are artifacts
Measured: 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
Measured: intraoperative (from the beginning to the end of anesthesia record)
causes of artifacts
to find out the cause of the artifact and respective percentage
Measured: intraoperative (from the beginning to the end of anesthesia record)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 May 2021
- Primary completion1 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArtifactsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Chung,Huang, Mackay Memorial Hospital
- Investigators
- Chien-Chung Huang, MD, Study director, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814941
- Sponsor's protocol ID
- 19MMHIS017e
- Status last verified
- Mar 2023
- First submitted
- 21 Jan 2019
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30153918Kool 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.
PubMed 22806063Hoorweg 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.
PubMed 28968279
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Incidence of Artifacts in the Locally Developed AIMS Database.
- ClinicalTrials.gov ID
- NCT03814941
- Acronym / sponsor ID
- 19MMHIS017e
- Keywords
- Artifacts, anesthesia information management system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the incidence of artifacts in the developed AIMS database
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paper-based anesthesia record | – | Other: paper-based anesthesia recordThe 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. |
| electronic documents | – | Other: electronic documentsThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergo general or regional anesthesia for surgery
Key inclusion criteria (2 listed)
- patient undergo general or regional anesthesia
- elective surgery
Key exclusion criteria (1 listed)
- emergency operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paper-based anesthesia recordto evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record | Other | paper-based anesthesia record |
| electronic documentsto evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record | Other | electronic documents |
Primary outcome
percentage of artifacts
Time frame: intraoperative (from the beginning to the end of anesthesia record)
to evaluate how many percentage of artifacts for each of the included parameters
4 secondary outcomes
deviating values
Time frame: intraoperative (from the beginning to the end of anesthesia record)
percentage of devotional artifacts
Time frame: intraoperative (from the beginning to the end of anesthesia record)
episodes of artifacts
Time frame: intraoperative (from the beginning to the end of anesthesia record)
causes of artifacts
Time frame: intraoperative (from the beginning to the end of anesthesia record)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 30153918Wilbanks 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.
- Background: PubMed 22806063Kool 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.
- Background: PubMed 28968279Hoorweg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Chung Huang, MD study director
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artifacts and Integrated Advanced Information Management Systems, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of artifacts (time frame: intraoperative (from the beginning to the end of anesthesia record)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814941, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.