The Effect of Intermittent Normal Saline Flush On Patency of Peripheral Venous Catheter and Prevention of Phlebitis and infiltration: a Single-Blind Randomized Controlled Trial
Aim: Investigation of the effect of intermittent normal saline flush on patency of peripheral venous catheter and prevention of phlebitis and infiltration in hospitalized patients in Imam Reza Hospital in Tabriz 1393.
design and Methods: A a Single-Blind Randomized Controlled Trial was conducted (the researcher who measured phlebitis).At each visit the patients, those who met inclusion criteria consecutively assigned in three groups, using a table of random numbers, Two intervention groups (Group I: n=50, intervention every 8 hours and the second group n=50, intervention every 12 hours), and a control group (n=50) with an allocation ratio of 1: 1: 1.
In the first intervention group every 8 hours and in the second intervention group every 12-hours, the intravenous catheter was flushed with 3 ml of normal saline solution for 72 hours (and also before and after every other infusion), and the control group not receiving the intervention according to current routine. Followed by 24-48-72 hours after the first intervention, Catheter complications observed by trained nurses using a structured check list.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062118176N1
Registration date:2014-08-30, 1393/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-30, 1393/06/08
Registrant information
Name
Morteza Fotowati
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 7713
Email address
fotowatim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz Nursing & Midwifery Faculty
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intermittent Normal Saline Flush On Patency of Peripheral Venous Catheter and Prevention of Phlebitis and infiltration: a Single-Blind Randomized Controlled Trial
Public title
The effect of saline lock on prevention of phlebitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: adult patients (Older than 18 years old) admitted to the medical-surgical wards that will hospitalized at least three days after surgery; patients with peripheral intravenous catheter in the upper limb (on the forearm) and patients who were willing to participate.
Exclusion criteria: patients who had any underlying blood disorders (eg, hemophilia, diabetes, etc); patients who receiving anticoagulant therapy (heparin, warfarin, Plavix, etc); patients who receiving IV potassium chloride; patients who receiving continuous intravenous fluid therapy; replacement of the catheter for any reason other than phlebitis; discharged or died during the study period; emergency situation that requires immediate medical or nursing interventions, such as cardiopulmonary resuscitation.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Variables such as gender and age,that affecting the incidence of phlebitis based on previous studies were lowered with random allocation of variable.
All catheters by one person and in the cephalic vein of the forearm will be fixed with once tried out.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Department of Tabriz University of Medical Sciences
Street address
No 2 Building -3 floor -Deputy Of Research-Tabriz University Of Medical Sciences- Golgasht st-Tabriz
City
Tabriz
Postal code
51665118
Approval date
2014-06-23, 1393/04/02
Ethics committee reference number
9350
Health conditions studied
1
Description of health condition studied
Phlebitis
ICD-10 code
T80.1
ICD-10 code description
Vascular complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Phlebitis
Timepoint
24-48-72 hours, respectively, after the pre-test
Method of measurement
Visual Analogue Scale phlebitis
Secondary outcomes
1
Description
Infiltration and the patency of the catheter
Timepoint
respectively, 24-48-72 hours after the pre-test
Method of measurement
Observation checklist and visual analogue scale infiltration
Intervention groups
1
Description
In the first intervention group, IV catheter, flushed with 3 ml of normal saline every 8 hours for 72 hours, also before and after of any injection.
Category
Treatment - Drugs
2
Description
In the second intervention group, IV catheter, flushed with 3 ml of normal saline every 12 hours for 72 hours, and also before and after of any injection.
Category
Prevention
3
Description
control group not receiving the intervention according to current hospital routines.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Morteza Fotowati
Street address
Imam Reza Hospital, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
No 2 Building -3 floor -Deputy Of Research-Tabriz University Of Medical Sciences- Golgasht st-Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery
Full name of responsible person
Morteza Fotowati
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati street