A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)

NCT ID: NCT04039906

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2019-09-23

Brief Summary

Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety when using ANDY(Automatic Needle Destroyer). Install ANDY(Automatic Needle Destroyer) in the ER, and evaluate the system by comparing the efficiency of the work, usability, actual decrease ratio of needlestick injury between using the automated needle processing system and not using it.

Detailed Description

1. Background The most frequent occupational injury is exposure to blood and fluid by needlestick injury. Needlestick injuries can result in serious infections if appropriate infection control measures are not taken promptly.

Since the use of safety devices are not popularly used, the needle and syringe are mostly taken into pieces by physical ways. There are some cases that the needle and syringe is not separated, and the entire syringe can be put directly into the waste container. There is also a problem that it takes a lot of time and efforts to remove needles from syringes. In addition, the existing safety mechanism is physical methods such as pulling out the needle, damaging or cutting the needle, or using heat to the needle, or melting it by using chemicals. It is a semi-manual since you have to wait holding the syringe during the process, and it is inconvenient to use considering a busy medical environment.

Therefore, we developed ANDY(Automatic Needle Destroyer) that can be introduced at a convenient and reasonable cost, and try to objectively evaluate the utility of ANDY in a clinical environment.

2. Purpose The purpose of this study is to Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety of the system.

3. Design : RCT (randomized controlled trial)

4. Setting: EMERGENCY CENTER at the Samsung Medical Center

5. Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box)

6. Intervention :

6-1) 1st Week : Removal of needle with existing method

• Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
• Identify the number of syringes processed by existing method.
• Do survey after 1st week

6-2) 2nd week: Prepare for using ANDYs

• Provide clinicians with instruction how to use ANDY
• Install 10 ANDYs in the ER.

6-3) 3rd week : Removal of needle with using ANDYs

• Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
• Identify the number of syringes processed by ANDY.
• After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees feel those are necessary.

7. Scoring: By the answers of the Questionnaire of Satisfaction (SUS and adjective score)

8. Study period : 3 weeks

9. Satisfaction survey: SUS and adjective score

Conditions

Needle Stick Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Removal of needle with existing method

Participants will remove needles from syringes with the existing method like they are already doing. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Removal of needle with using ANDYs

Participants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)

Group Type: EXPERIMENTAL

Removal of needle with using ANDYs

Intervention Type: DEVICE

1. ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days

2. Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.

Identify the number of syringes processed by ANDY.

3. After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees felt those are necessary.

Interventions

Removal of needle with using ANDYs

1. ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days

2. Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.

Identify the number of syringes processed by ANDY.

3. After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees felt those are necessary.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• medical staff of the ER
• adult ER medical staff over 19 years of age
• A subject who voluntarily agrees and signs

Exclusion Criteria

•A subject who did not agree with this study

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

TAERIM KIM, Doctoral

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2019-05-112

Identifier Type: -

Identifier Source: org_study_id