Comparing of local warming and intravenous assistive device (vein viewer) on duration and first attempt success rate for inserting of peripheral venous catheter in 1- 36 months pediatrics referred to pediatric ward of imam Khomeini hospital in esfarayen, iran
Determine effects of comparing of local warming and intravenous assistive device (vein viewer) on duration and first attempt success rate for inserting of peripheral venous catheter in 1- 36 months pediatrics referred to pediatric ward
Design
A randomized controlled clinical trial study with four groups(three intervention and one control group), parallel and randomized groups
Settings and conduct
This study is performed in pediatric ward of Imam Khomeini Hospital in Esfarayen. The study population is children (1– 36 months) referred to the pediatric ward for hospitalization. After obtaining the consent of the child's parents, they assigned in one of the four groups (local warming, vein viewer device, local heat and vein viewer device, and control group) based on a random number table.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patient should be difficult for peripheral catheter insertion (DIVA score greater than 3)
2- Age less than 36 months and more than one month.
3 - Catheter insertion is done on upper limb.
Exclusion Criteria:
1- Parental unwillingness to cooperate
2- Catheter insertion Failure for first attempt
3- Patient has a emergency condition
Intervention groups
In the vein viewer device group, infra red waves illuminate 90 degrees at determined site by nurse and catheter will insert.
In the local warming group, the "hot-water bottle" (40 c) will has put on for 2 minutes in site of catheterization.
In the third group (local warming plus vein viewer) the "hot-water bottle" will has put on for 2 minutes then infra red waves of vein viewer device illuminated 90 degrees at determined site.
In the fourth group, nurse fasten tourniquet and based on their previous experience insert the catheter after disinfection site with Alcohol 70%.
Main outcome variables
Duration and first attempt success rate for inserting of catheter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045773N1
Registration date:2020-01-22, 1398/11/02
Registration timing:prospective
Last update:2020-01-22, 1398/11/02
Update count:0
Registration date
2020-01-22, 1398/11/02
Registrant information
Name
seyed javad hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 2650
Email address
s.j.hoseini2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of local warming and intravenous assistive device (vein viewer) on duration and first attempt success rate for inserting of peripheral venous catheter in 1- 36 months pediatrics referred to pediatric ward of imam Khomeini hospital in esfarayen, iran
Public title
Effect of local warming and vein viewer on success rate for inserting of peripheral venous catheter in pediatrics
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 36 months and more than one month.
Patients require to the insert of catheter
Exclusion criteria:
Parental unwillingness to cooperate
Patient has a emergency condition.
Age
From 1 month old to 36 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are randomly assigned to four groups using a random number table. Numbers 00-24 for local warming intervention, 25-49 numbers for vein viewer intervention, 50-74 numbers for local warming with vein viewer group device and numbers 75-99 are considered for the control group. The researchers then put on one of the numbers on the table of random numbers and move to the right and down of the table. We record the numbers and assign them to different groups.
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 Esfarayen faculity of Medical Sciences
Street address
Faculity of Medical Sciences, Imam Reza S.t, Esfarayen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
96618-76981
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.ESFARAYENUMS.REC.1398.008
Health conditions studied
1
Description of health condition studied
Diarrhea
ICD-10 code
R19.7
ICD-10 code description
Diarrhea, unspecified
2
Description of health condition studied
Pneumonia
ICD-10 code
A37.91
ICD-10 code description
Whooping cough, unspecified species with pneumonia
3
Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
First attempt success rate for inserting of peripheral venous catheter
Timepoint
Immediately after fixation of catheter on the skin
Method of measurement
Possible to injection of "water for injection" from the Y-shaped part of the "Micro Drop Infusion Set" without causing swelling at the top of catheter insertion
2
Description
Inserting of peripheral venous catheter duration
Timepoint
Since initiation catheter insertion until it is fixed in place
Method of measurement
Using the Stopwatch
3
Description
The time spent to find a peripheral venous
Timepoint
Since the fasten of tourniquet to start inserting of peripheral venous catheter
Method of measurement
Using the Stopwatch
Secondary outcomes
empty
Intervention groups
1
Description
Vein viewer device group: After fasten the tourniquet on the upper limbs (hands), nurse turn on vein viewer device (Vein light LED plus) and illuminate at 90 degrees in skin. After observing the vein, 70% alcohol is rubbed site, then the peripheral catheter N.24 will be inserted.
Category
Other
2
Description
In the intervention local warming group , Nurse fasten the tourniquet and determine a suitable vein. then, she open tourniquet and put on"hot-water bottle" (40 ° C ) that wrapped in a texture( temperature will be confirmed by laser thermometer) in site of catheter insertion. it remain on the skin for 2 min. skin temperature is checked every 30 seconds. Again, the tourniquet is fastened in the upper limb and peripheral catheter will be inserted at a predetermined site.
Category
Other
3
Description
Combination Intervention group (local warming plus vein viewer device) : Nurse fasten the tourniquet and determine a suitable vein. Then, she open tourniquet and put on "hot-water bottle" (40 ° C ) in site of catheter insertion that wrapped in a texture( temperature will be confirmed by laser thermometer). It remain on the skin for 2 min. skin temperature is checked every 30 seconds. Again, the tourniquet is fastened in the upper limb, nurse turn on vein viewer device (Vein light LED plus) and illuminate at 90 degrees on skin. After observing the vein, 70% alcohol is rubbed site, then the peripheral catheter N.24 will be inserted.
Category
Other
4
Description
In control group, nurse fasten tourniquet and based on their previous experience insert the catheter after disinfection site with Alcohol 70%.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfarāyen Imam Khomeini Hospital
Full name of responsible person
Seyed Javad Hosseini
Street address
Imam Reza S.t, Esfarāyen Town
City
Esfarayen
Province
North Khorasan
Postal code
96618-76981
Phone
+98 58 3722 6005
Email
s.j.hoseini2016@gmail.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 S.t, Esfarāyen Faculty of Medical Sciences
City
Esfarayen
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
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Master of Nursing , Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarāyen Faculty of Medical Sciences , Imama Reza S.t, Esfarāyen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
76981-96618
Phone
0098 5831550000- 602
Email
s.j.hoseini2016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Master of science- Member of faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarāyen Faculty of Medical Sciences , Imam Reza S.t, Esfarāyen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
76981-96618
Phone
+98 58 3723 2650
Email
s.j.hoseini2016@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Seyed Javad Hosseini
Position
Master of science- member of faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Esfarāyen Faculty of Medical Sciences, Imam Reza S.t, Esfarāyen, North Khorasan
City
Esfarayen
Province
North Khorasan
Postal code
76981-96618
Phone
+98 58 3723 2650
Email
s.j.hoseini2016@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Documentation is registered "Pajouhan" system after completion of the study . Also, participants general information and the effectiveness of interventions will be recorded in the article.
When the data will become available and for how long
Accessibility after publish of article
To whom data/document is available
People interested in pediatric nursing scope
Under which criteria data/document could be used
People looking for ways to facilitate catheter insertion in pediatric who can access the data
From where data/document is obtainable
Faculty of Medical Sciences Esfarāyen, imama reza s.tEsfarāyen,North Khorasan
What processes are involved for a request to access data/document
They can access to data through below email as soon as possible
s.j.hoseini2016@gmail.com