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Comparison of operator workloads during a changeover of continuous infusion from syringe pump to infusion pump: new method using an ANYFUSION versus conventional method using a syringe pump and an infusion pump

Status Approved

First Submitted Date

2019/07/29
Registered Date

2019/08/09
Last Updated Date

2019/08/08

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004172
Unique Protocol ID	SMC 2019-04-061-04
Public/Brief Title	Comparison of operator workloads during a changeover of continuous infusion from syringe pump to infusion pump
Scientific Title	Comparison of operator workloads during a changeover of continuous infusion from syringe pump to infusion pump: new method using an ANYFUSION versus conventional method using a syringe pump and an infusion pump
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SMC 2019-04-061-04
Approval Date	2019-07-08
Institutional Review Board Name	Institutional Review Board of Samsung Medical Center
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	JUNG JIN MIN
Title	Associate professor
Telephone	+82-2-3410-5257
Affiliation	Samsung Medical Center
Address	Samsung Medical Center, Irwon-Ro 81, Gangnam-Gu, Seoul, 06351, Republic of Korea
Contact Person for Public Queries
Name	DUK KYUNG KIM
Title	Professor
Telephone	+82-2-3410-0343
Affiliation	Samsung Medical Center
Address	Samsung Medical Center, Irwon-Ro 81, Gangnam-Gu, Seoul, 06351, Republic of Korea
Contact Person for Updating Information
Name	DUK KYUNG KIM
Title	Professor
Telephone	+82-2-3410-0343
Affiliation	Samsung Medical Center
Address	Samsung Medical Center, Irwon-Ro 81, Gangnam-Gu, Seoul, 06351, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-20 Anticipated
Target Number of Participant	22
Primary Completion Date	2019-10-25 , Anticipated
Study Completion Date	2019-11-15 , Anticipated
Name of Study	Samsung Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-20 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Health Industry Development Institute
Organization Type	Others
Project ID	없음

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea Health Industry Development Institute
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	Cardiovascular drugs are often administered via syringe pump or infusion pump. Though syringe pump can deliver at more precise rate than infusion pump, it requires changeovers on a regular basis due to its limited syringe capacity to ensure a continuous supply of the drug. Thus, when leaving from operating room to ward or intensive care unit, a changeover from a syringe pump to infusion pump occurs frequently. However, it causes an increase in medical personell's workload, thereby increasing the risk of unwanted interruption of drug administration. Such a situation can potentially can cause severe alteration in hemodynamic stability. ANYFUSION is the world's first developed infusion device which combines infusion pump and syringe pump into one unit pump. In this prospective, randomized, crossover-designed simulated study, we will therefore compare the clinical workload of new changeover method using an ANYFUSION with a conventional method using two infusion devices (a syring pump and an infusion pump).

Study Summary Information

Lay Summary

Cardiovascular drugs are often administered via syringe pump or infusion pump. Though syringe pump can deliver
 at more precise rate than infusion pump, it requires changeovers on a regular basis due to its limited syringe
capacity to ensure a continuous supply of the drug. Thus, when leaving from operating room to ward or intensive care unit, a changeover from a syringe pump to infusion pump occurs frequently. However, it causes an increase in medical personell&#39;s workload, thereby increasing the risk of unwanted interruption of drug administration. Such a situation can potentially can cause severe alteration in hemodynamic stability. ANYFUSION is the world&#39;s first developed infusion device which combines infusion pump and syringe pump into one unit pump. In this prospective, randomized, crossover-designed simulated study, we will therefore compare the clinical workload of new changeover method using an ANYFUSION with a conventional method using two infusion devices (a syring pump and an infusion pump).

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-crossover
Time Perspective	Prospective
Target Number of Participant	22
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Conventional changeover method
Cohort/ Group 1	Cohort/Group Description conventional changeover method using two infusion devices (a syringe pump and an infusion pump)
Cohort/ Group 2	Cohort/Group Label New changeover method using an ANYFUSION
Cohort/ Group 2	Cohort/Group Description new changeover method using a single infusion device (ANYFUSION)
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	nurses of department of Anesthesiology and Pain Medicine in Samsung Medical Center who consent the participation of this study
Sampling Method	Purposive sampling (Samsung Medical Center recovery room or anesthesia nurses who voluntarily participate this study)
Condition(s)/Problem(s)	Not Applicable-Medical equipment Not applicable (simulated study uaing a dummy model)
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description participants who receive a 2-hour practical demonstration of operation with the relevant devices, followed by a 4-week training course including practical work
Exclusion Criteria	not applicable.
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	clinical-equivalence
Outcome	total execution time, defined as time taken from the setup with a syringe pump mode to the administration of the medication via a changed infusion pump mode.
Timepoint	After the completion of the task
Secondary Outcome(s) 1
Outcome	total number of clicks
Timepoint	After the completion of the task
Secondary Outcome(s) 2
Outcome	subjective difficulty score using a numerical rating scale with a score from 0 (extremely easy) to 10 (extremely difficult)
Timepoint	After the completion of the task

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2020. 10
Way of Sharing	Public Repository (http://한국보건산업진흥원 홈페이제에 과제 결과보고서 형태로 게재)

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