Protocol summary

Study aim
Determine the comparative effect of continuous versus pulsative flushing on the phlebitis incidence, patency and longevity of peripheral intra venous catheter in patients admitted to medical and surgical wards of Eesfarayen Hospital
Design
A clinical trial study of three groups, single blind and randomize assignment.
Settings and conduct
After obtaining Ethics Committee permission and permission from Esfarayn faculty of Medical Sciences and the officials of Imam Khomeini Esfarayn Hospital, first choose sample selection with form then eligible patients were selected using a goal-based sampling method and then explained. The purpose of the research and how it will be done, the patients will receive written consent to participate in the research, and they will be informed that they can be dissuaded from continuing to participate in the research whenever they wish.
Participants/Inclusion and exclusion criteria
The participants of this study are patients admitted to the internal and surgical wards of Imam Khomeini Hospital Esfarayne. inclusion includes patients18 to 65 years old that hospitalized for at least 96 hours and exclusion criteria including taking an anticoagulant drugs.
Intervention groups
In the first intervention group (pulsative flushing), before injection of the first drug into the intravenous catheter, five milli liter(m.l) of the 0.9% Nacl solution, which Pre-prepared into 5-m.l syringe,put up top of the catheter that had one-way valve.Then, one m.l of the solution is injected into the catheter within one second, then 0.4 seconds is interrupted and again one m.l is injected within one second, this procedure continues until the evacuate five milliliters 0.9% Nacl solution.Then the patient's drug is injected in accordance with the leaflet or the physician's order، After the drug is finished, if they have another drug, before the second drug is injected, the pulsative Flushing method described above is repeated and then the second drug is injected. These steps will continue until patient medications to be completed . Finally, locking technique performed(one m.l of 0.9% Nacl solution is slowly injected with a two m.l syringe through heparin lock that located at the end of the p.v.c) and the patient's catheter until the next patient's drug is administered remains intact(minimum time is six hours from the last injection). In the second intervention group (pulsative flushing), before injection of the first drug into the intravenous catheter, five milli liter(m.l) of the 0.9% Nacl solution, which Pre-prepared into 5-m.l syringe,put up top of the p.v.c that had one-way valve. Injection will be done within 5 seconds.Then the patient's drug is injected in accordance with the leaflet or the physician's order، After the drug is finished, if they have another drug, before the second drug is injected, the continous flushing method described above is repeated and then the second drug is injected. finally locking technique performed. In the control group, drugs are injected at a predetermined time.
Main outcome variables
Peripheral catheter phlebitis: The patient score obtains from a phlebitis visual check list. patency of p.v.c : Lack of resistance to drug injection with or without blood return. Longevity of p.v.c : period of time which there is not evidence shows the catheter functional ended or catheter is not prohibited, time will be recorded per hours(maximum time is 96 hours).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141222020394N4
Registration date: 2018-02-04, 1396/11/15
Registration timing: registered_while_recruiting

Last update: 2018-02-04, 1396/11/15
Update count: 0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Mahbobeh Firooz
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 2650
Email address
mahbobehfirooz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Esfarayen University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of continuous versus pulsative flushing on the phlebitis incidence , patency and longevity of peripheral intra venous catheter in patients admitted to medical and surgical ward of Eesfarayen Hospital
Public title
Comparing the effect of continuous versus pulsative flushing on the phlebitis incidence, patency and longevity of peripheral intra venous catheter
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 65 years old at least 96 hours are hospitalized
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
PASS software
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be a single blind. After giving explanations to the patients about the method of study completely and consent of patients, they fall into one of the three groups of continuous flushing, pulsative flushing and control group that they are not informe about type of group. Next,assigned to the patient a code. numbers: one, four , Seven, ... belong to continuous Flushing , numbers: two, five, eight, ... belong to Flushing group and numbers: three, six, nine, and ... belong to the control group.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Blvd Tohid Shahr,sabzevar town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-01-04, 1395/10/15
Ethics committee reference number
IR.MEDSAB.REC.1395.112

Health conditions studied

1

Description of health condition studied
This study was performed on patients admitted to medical and surgical department of Eesfarayen Hospital
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Phlebitis incidence
Timepoint
Every 12 hours to 4 days
Method of measurement
Visual Infusion Phelebit Scale

2

Description
Catheter patency
Timepoint
Every 12 hours to 4 days
Method of measurement
lack of resistant against injection from peripheral intra venous catheter

3

Description
longevity of peripheral intra venous catheter
Timepoint
Every 12 hours to 4 days
Method of measurement
Maximum catheter longevity in situ is 96 hours

Secondary outcomes

1

Description
phelebitis of peripheral intra venous catheter
Timepoint
Every 12 hours For 4 days
Method of measurement
Visual Infusion Phelebit Scale

2

Description
Catheter patency
Timepoint
Every 12 hours For 4 days
Method of measurement
lack of resistance against of injection

3

Description
Catheter longevity
Timepoint
Every 12 hours For 4 days
Method of measurement
catheter remain in situ for maximum for 96 hours.

Intervention groups

1

Description
Intervention group1: patients admitted to medical and surgical ward; interventions includ: pulsative flushing in time of drug administration, and then check the phlebitis incidence, patency and longevity of peripheral intra venous catheter every 12 hour
Category
Prevention

2

Description
Intervention group2: patients admitted to medical and surgical ward; interventions includ: continuous flushing in time of drug administration, and then check the phlebitis incidence, patency and longevity of peripheral intra venous catheter every 12 hou
Category
Prevention

3

Description
Control group: Patient drugs are injected according to pre determinated time , and every 12 hours to 96 hours, the catheter is controlled by phlebitis and patency.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Esfarāyen
Full name of responsible person
mahbobeh firooz
Street address
Imam Reza Street, Esfarāyen Town
City
Esfarāyen
Province
North Khorasan
Postal code
96618-76981
Phone
+98 58 3722 6005
Email
mahbobehfirooz@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Eshagh Ildarabadi
Street address
Imam Reza Street , Faculty of Medical Sciences Esfarāyen
City
Esfarāyen
Province
North Khorasan
Postal code
76981-96618
Phone
+98 58 3724 1604
Email
ildarabadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Medical Sciences Esfarāyen
Full name of responsible person
Mahbobeh firooz
Position
Master of Nursing , Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Medical Sciences Esfarāyen,Esfarāyen,North Khorasan
City
Esfarāyen
Province
North Khorasan
Postal code
9661777944
Phone
+98 58 3723 2650
Fax
Email
mahbobehfirooz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Medical Sciences Esfarāyen
Full name of responsible person
Mahbobeh firooz
Position
MS Nursing , Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Medical Sciences Esfarāyen,Esfarāyen,North Khorasan
City
Esfarāyen
Province
North Khorasan
Postal code
961777944
Phone
+98 58 3723 2650
Fax
Email
mahbobehfirooz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Mahbobeh firooz
Position
MS Nursing , Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Medical Sciences Esfarāyen, Esfarāyen , North Khorasan
City
Esfarāyen
Province
North Khorasan
Postal code
9661777944
Phone
+98 58 3723 2650
Fax
Email
Mahbobehfirooz@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is not more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study report will be published in the form of articles in journals
When the data will become available and for how long
After the publication in the journal
To whom data/document is available
All interested in the subject of the study
Under which criteria data/document could be used
In order to use it in clinical practice
From where data/document is obtainable
Electronic databases
What processes are involved for a request to access data/document
search done by purposful keywords includes:"flushing", "phlebitis", "patency of peripheral catheter"
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