The aim of this study is determination of the peripheral intravenous catheter complications during 72 and 96 hours after insertion, which is experimentally performed on patients after coronary artery bypass graft in heart surgery ward, in single blind way and using random block randomization sampling method. The inclusion criteria for the selection of samples: 1. Need to peripheral venous catheter for at least 72 hours. 2. Absence of any known Peripheral vascular disease 3. Receiving no immunosuppressive drugs. 4. Absence of bloodstream infection. 5. Lack of sensitivity to penicillin and receiving antibiotics according to routine protocol of heart surgery ward. The exclusion criteria include: 1. Changes in the type of intravenous medications during the study that cuts the sameness of drugs received by samples. 2. Accidental removal of catheter. 3. Removal of catheter when treatment is completed. 4. Skin allergy to adhesive dressing on catheter 5. Refusal to participate in research. The control group consist of 48 patients. Catheter replacement is done within 72 hours using routine method. There are 75 patients in intervention group. If the catheters of this group function properly to 72 hours, without any complications, will not be removed and the patient will be considered for 96 hours. After 96 hours, the catheter will be changed even if the catheter complications do not occur. In both groups, Catheters will be investigated in terms of complications including phlebitis, infiltration and occlusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062419617N3
Registration date:2015-07-14, 1394/04/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-14, 1394/04/23
Registrant information
Name
Ezzat Paryad
Name of organization / entity
Guilan University of Medical Sciences, Shahid Beheshti Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
e_paryad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of peripheral catheter complications during 72 and 96 hours after insertion
Public title
Comparison of peripheral catheter complications during 72 and 96 hours after insertion
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: Need to peripheral venous catheter for at least 72 hours; Absence of any known Peripheral vascular disease (based on medical documents); Receiving no immunosuppressive drugs (based on medical documents); Absence of bloodstream infection (based on medical documents); Lack of sensitivity to penicillin and receiving antibiotics according to routine protocol of heart surgery ward
exclusion criteria: Changes in the type of intravenous medications during the study that cuts the sameness of drugs received by samples; Accidental removal of catheter; Removal of catheter when treatment is completed; Skin allergy to adhesive dressing on catheter; Refusal to participate in research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
vice chancellor for research of Guilan university of medical science
Street address
Shahid Beheshti west boulevard, opposite of Sepah Bank, top of agency of Iran radiator, vice chancellor for Research Building
City
Rasht
Postal code
Approval date
2015-06-09, 1394/03/19
Ethics committee reference number
IR.GUMS.REC.1394.51
Health conditions studied
1
Description of health condition studied
complications of intravenous therapy
ICD-10 code
T80
ICD-10 code description
Complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
phlebitis at insertion site
Timepoint
in any shift until 72 and 96 hours
Method of measurement
the Infusion Nurses Sciety phlebitis scale
2
Description
infiltration
Timepoint
in any shift until 72 and 96 hours
Method of measurement
the Infusion Nurses Society infiltration scale
3
Description
occlusion of catheter
Timepoint
in any shift until 79 and 96 hours
Method of measurement
absence of serum flow even after aspiration
Secondary outcomes
empty
Intervention groups
1
Description
In control group, Catheter replacement is done within 72 hours using routine method without intervention.
Category
N/A
2
Description
in intervention group, If the catheters function properly to 72 hours, without any complications, will not be removed and the intervention in the form of keeping catheters to 96 hours will be performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat educational and medical center
Full name of responsible person
Ezzat Paryad
Street address
Shahid Beheshti highway, 15 Khordad avenue, Next to the Management and Planning Organization in Guilan Province
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Dr Abtin Heidarzade
Street address
Shahid Beheshti west boulevard, opposite of Sepah Bank, top of agency of Iran Radiator, vice chancellor for research building
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science
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
Guilan University of Medical Science
Full name of responsible person
Ezzat Paryad
Position
nursing master of science/member of faculty
Other areas of specialty/work
Street address
Shahid Beheshti highway, Daneshjoo street, Shahid Beheshti Nursing and Midwifery School
City
Rasht
Postal code
4146939841
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
e_paryad@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guian University of Medical Science
Full name of responsible person
Ezzat Paryad
Position
nursing master of science
Other areas of specialty/work
Street address
Shahid Beheshti highway, Daneshjoo street, Shahid Beheshti Nursing and Midwifery school
City
Rasht
Postal code
4146939841
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
e_paryad@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Ezzat Paryad
Position
nursing master of science
Other areas of specialty/work
Street address
Shahid Beheshti highway, Daneshjoo street, Shahid Beheshti Nursing and Midwifery school
City
Rasht
Postal code
4146939841
Phone
+98 13 3355 3202
Fax
+98 13 3357 0097
Email
e_paryad@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Sharing plan
Deidentified Individual Participant Data Set (IPD)