To determine the effect of Near-Infrared Vein Finder Technology successful rate of cannulation in obese diabetic patients.
Design
A randomized control trail design with concurrent control group
Settings and conduct
In the intervention group, the patient lies on his back on the bed and the sleeves of his clothes are raised. The device is then turned on and the vessels of the patient's hand are examined, The time will be calculated from turning on until the catheter is inserted into the vessel successfully. If not successful, the venipuncture will be repeated. If the venipuncture fails up to 4 times, the patient will be excluded from the study.
In the control group, venipuncture for the patient will be performed routinely by the same nurse in the intervention group. The duration of venous cannulation is considered from the time of tying the tourniquet.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least two months have passed since the diabetic type 2, Body mass index 30 and above, Having patients' informed consent, Age between 18-70 years, No history of vein problems, Not having vein problems such as phlebitis and extremities edema.
Exclusion criteria: Reluctance to continue participating in the study, Exacerbation of the disease or occurrence of an unpleasant accident for the patient such as severe hemorrhage and hematoma, Failing insertion of cannula at more than fourth attempt .
Intervention groups
In the intervention group, an infrared vein finder will be used to find the patient's upper extremity veins.
Main outcome variables
The number of attempts and the procedural time of cannulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210705051797N1
Registration date:2021-08-05, 1400/05/14
Registration timing:prospective
Last update:2021-08-05, 1400/05/14
Update count:0
Registration date
2021-08-05, 1400/05/14
Registrant information
Name
Saeb Al-Saadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
alsaedis982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Near Infrared Vein Finder Technology on Successful rate of Cannulation in Obese Diabetic Patients
Public title
Effect of using infrared vein finder on the success rate of venipuncture in obese diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnose diabetes for at least two months
Body mass index 30 and above
Having patients' informed consent
Age between 18-70 years
No history of vein problems
Not having vein problems such as phlebitis and extremities edema
Exclusion criteria:
Reluctance to continue participating in the study
Exacerbation of the disease or occurrence of an unpleasant accident for the patient such as severe hemorrhage and hematoma
Failing insertion of cannula at more than fourth attempt
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are selected based on the inclusion criteria and then randomly assigned to the intervention or control group by coin lottery.
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 Mashhad University of Medical Sciences
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Doctora Croddroad, Daneshgah Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-07-06, 1400/04/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.037
Health conditions studied
1
Description of health condition studied
Obese Diabetic Patients
ICD-10 code
E11.69
ICD-10 code description
Type 2 diabetes mellitus with other specified complication
Primary outcomes
1
Description
the number of attempts of cannulation
Timepoint
during the study
Method of measurement
Counting the number of times that catheter is inserted into the patient's skin.
2
Description
Duration of catheter insertion
Timepoint
duration of the study
Method of measurement
Measure the time required for catheter insertion using a watch
Secondary outcomes
1
Description
no having
Timepoint
no having
Method of measurement
no having
Intervention groups
1
Description
In the intervention group, an infrared vein finder will be used to examine the patient's veins and catheter insertion.
Category
Prevention
2
Description
In the control group, routine procedures are used for catheter insertion and no vein finder will be used.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Kindy hospital
Full name of responsible person
Saeb Al-Saadi
Street address
Al-Nahdha
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Fax
Email
saebalsaadi927@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen tafaghodi
Street address
Danshgah Street/ Doctora crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Email
tafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Mashhad 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
Sponsor: country of origin
Country of origin
IQ
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Professor; Hossein Karimi Moonaghi, PhD.
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Danshgah street/ Doctora crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimih@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Professor, Hossein Karimi Moonaghi, PhD.
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Danshgah street/ Doctota crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Professor, Hossein Karimi Moonaghi, PhD.
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Danshgah street/ Doctora crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimih@mums.ac.ir
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
Not applicable
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications.
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: saebalsaadi927@gmail.com
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.