Compare the effect of temperature equalization of intravenous administration with body temperature and intravenous administration with environment temperature on occurrence of phlebitis and dwell time of short peripheral intravenous catheter in patients admitted to internal ward of Emam Ali' hospital in Sarayan
Objectives: Survey of the effect of temperature equalization of intravenous administration with body temperature on occurrence of phlebitis and dwell time of intravenous catheters. Design: This study is a randomized clinical trial. The sample includes 106 patients undergoing intravenous administration in Emam Ali hospital of Sarayan city in province of South Khorasan in Iran will be allocated alternately in control (53) and intervention (53) groups by permutation blocks with four blocks. Setting and conduct: First, a checklist will be used to collect demographic data and information related to infusion. After qualifying for inclusion, catheter 22 gage according to Infusion Nursing Society (INS) standards will be inserted to vein in anterior forearm (away from elbow and wrist) by trained nurses. In intervention group; Solutions and medications will be infused by infusion pump SN-1500SERIAL (made in china) at range of body normal temperature (37℃) and in control group (solutions and Medications, similar to the intervention group) will be infused at a mean temperature of environment (24℃) by infusion pump. Insertion sites were observed every 2 hours for evidence of phlebitis according to INS Phlebitis Scale and dwell time of catheter determined at hours. 1 and 2 degrees of phlebitis scale will be considered as occurrence of Phlebitis and dwell time of catheters based on hours (between insertion and discontinuing of catheter) will be measured. For analyzing of finding, descriptive and inferential statistics will be used. Significant level will be considered less than 0.05. Intervention: temperature equalization of intravenous administration with body temperature (37) in intervention group and intravenous administration at a mean temperature of environment (24℃) on control group. Main outcome Measures: Occurrence of phlebitis and dwell time of intravenous catheter.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011531959N1
Registration date:2017-02-19, 1395/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Amin Pirooz Seghaleh
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 9146
Email address
apirooz3ca@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Gonabad University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of temperature equalization of intravenous administration with body temperature and intravenous administration with environment temperature on occurrence of phlebitis and dwell time of short peripheral intravenous catheter in patients admitted to internal ward of Emam Ali' hospital in Sarayan
Public title
The effect of temperature of intravenous administration on occurrence of phlebitis and dwell time of intravenous catheters.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Having informed consent for research; Age 18-65 years; having full consciousness; not having underlying diseases such as leukemia; immune deficiency and dermatitis; healthy upper limb, do not receive Immunosuppressant’s drug and chemotherapy; having a minimum of 72 hours intravenous catheter; don’t receive drugs that stimulate the vein wall and solution Hyperosmolar; no history of intravenous drug addiction.
Exclusion Criteria: Disrupting or failure to completing the study because of transition to other unit or death; unwillingness to continue the study; need to receive stimulating and Hyperosmolar solutions and drugs during the study; receive intravenous fluids and medications less than 72 hours; sensitivity to adhesives.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Next to the Asian road
City
Gonabad
Postal code
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.GMU.REC.1395.57
Health conditions studied
1
Description of health condition studied
Phlebitis
ICD-10 code
I80.8
ICD-10 code description
Phlebitis and thrombophlebitis of other sites
Primary outcomes
1
Description
Phlebitis
Timepoint
24, 48 and 72 hours after intervention
Method of measurement
Phlebitis Scale from the Infusion Nurses society
Secondary outcomes
1
Description
Dwell time of intravenous catheter
Timepoint
Time between insertion and discontinue of catheter
Method of measurement
Per hour
Intervention groups
1
Description
Intervention group: temperature equalization of intravenous administration with body temperature (37℃) with infusion pump.
Category
Prevention
2
Description
In control group: intravenous administration at a mean temperature of environment (24℃) with infusion pump.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Amin Pirooz
Street address
Emam Ali Hospital, Shafa boulevard
City
Sarayan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Gonabad University of Medical Sciences
Full name of responsible person
Alii Mohammadpur
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amin Pirooz
Position
MSc in Nursing
Other areas of specialty/work
Street address
Vice Chancellor for education, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Apirooz3ca@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Mojalli
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Vice Chancellor for education, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Mojalli.m@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amin Pirooz
Position
MSc in Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
Fax
Email
Apirooz3ca@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)