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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025080
Receipt No. R000028576
Scientific Title Novel preparation method of intravenous infusion therapy of treprostinil in pulmonary arterial hypertension
Date of disclosure of the study information 2016/11/30
Last modified on 2017/08/28

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Basic information
Public title Novel preparation method of intravenous infusion therapy of treprostinil in pulmonary arterial hypertension
Acronym Novel preparation method of intravenous infusion therapy of treprostinil in PAH
Scientific Title Novel preparation method of intravenous infusion therapy of treprostinil in pulmonary arterial hypertension
Scientific Title:Acronym Novel preparation method of intravenous infusion therapy of treprostinil in PAH
Region
Japan

Condition
Condition pulmonary arterial hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using glucose,compare work time and work process of Standard method(S) and New method(N) which is treprostinil preparation method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adjustment time, adjustment error due to difference in preparation method
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Perform two different procedures
Interventions/Control_2 Perform two different procedures
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 2nursing nurses with clinical experience.
Nursing student aged20years and over and taking all injection lectures.
When participating in this research, after having received sufficient explanation, those who fully understand the contents of the research and obtained document consent by the target person's free will
Key exclusion criteria Nurse undergoing work restrictions.
Lecture on injection technique Students who have not taken exercise.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiko Igawa
Organization Nagasaki University Hospital
Division name Nursing department
Zip code
Address 1-7-1 Sakamoto Nagasaki City
TEL 095-819-7468
Email igasachi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiko Igawa
Organization Nagasaki University Hospital
Division name Outpatient department (2nd floor)
Zip code
Address 1-7-1 Sakamoto Nagasaki City
TEL 095-819-7468
Homepage URL
Email igasachi@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital Nursing department
Institute
Department

Funding Source
Organization Nagasaki University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
METHODS: The survey was conducted on two groups of nurses and students. The target was the name.30 nurse workers (average age 37.0 years old) with university hospital clinical experience of 1 year or more who conducts the injection procedure on a daily basis, 21students (average age 21.2 years old) who took lectures on injection at the nursing college To prepare the diluent, physiological saline was used as a solvent, and a 5% dextrose solution was substituted for Treprostinil injection solution. For the survey, diluent preparation was carried out 5 times for S method and N dilution preparation respectively, and the preparation time for each test was measured. As a diluent concentration measurement, a blood sugar measuring device was used. Evaluation items were "dispersion of concentration of diluent", "time required for preparation", "degree of difficulty of preparation" of each nurse / student.
RESULTS: There were no significant differences in dilution concentration between nurses and students, but there was a tendency for variation to be large for nursing practitioner N law and student S law. The total time taken for 5 preparations was short for both nurses and students (p <0.001), and preparation difficulty was easy for both nurses and students (p <0.001).
Conclusion: The method N is simple and easy to prepare in a short time without any problems in the preparation of the diluent, and it can be proposed as one of the methods for preparing the treprostinil diluent by the patient himself.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2017 Year 02 Month 10 Day
Date of closure to data entry
2017 Year 02 Month 15 Day
Date trial data considered complete
2017 Year 03 Month 16 Day
Date analysis concluded
2017 Year 03 Month 16 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2017 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028576

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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