A clinical trial with a control group, with two parallel arms, one-way blind, randomized, and phase 2 on 60 patients. A sealed envelope will be used for randomization.
Settings and conduct
The study will be conducted as a clinical trial at 3-month intervals in the General Intensive Care Unit and Brain Surgery. The intervention group in the general intensive care unit will be monitored by a checklist prepared for the proper care of the central vein catheter, and the control group in the intensive care unit of the brain surgery will be performed without a checklist and according to the usual care routine.
Participants/Inclusion and exclusion criteria
CV line for at least 48 hrs
admission in the ICU
Intervention groups
Intervention group: 30 patients admitted to the General Intensive Care Unit who will have a central catheter for at least 48 hours and will receive standard care along with routine care.
Control group: 30 patients admitted to the intensive care unit of brain surgery who will have a central catheter for at least 48 hours and will receive only routine care.
Main outcome variables
Redness around the catheter
Pus and discharge from the tunnel and inside the catheter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211109053016N1
Registration date:2022-05-19, 1401/02/29
Registration timing:retrospective
Last update:2022-05-19, 1401/02/29
Update count:0
Registration date
2022-05-19, 1401/02/29
Registrant information
Name
Behrouz Naghili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 5411
Email address
naghili_b@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of improving the performance of central venous catheter care in the intensive care unit
Public title
The effect of improving the performance of central venous catheter care
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
CV line for at least 48 hrs
Admission in the ICU
People over 14 years old
Completion of written informed consent form by the patient or companions in case of unconsciousness
Exclusion criteria:
Having neurological disorders (stroke-Parkinson's disease) and known psychological diseases based on patient statement and medical record
Having chronic uncontrollable diseases (such as advanced diabetes and malignancies)
Age
From 14 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
monitoring of catheter infection at periodic visit
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
First, patients or patient companions will receive information about the research and study groups, as well as how the groups are cared for. They will then be randomly assigned to one of the study groups using a sealed envelope. But they will not know which care is used or in which group.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshghah St. Emamreza Hospital - Infectious Diseases Department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2021-09-13, 1400/06/22
Ethics committee reference number
IR.TBZMED.REC.1400.576
Health conditions studied
1
Description of health condition studied
Control of nosocomial infections
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction of catheter associated infection
Timepoint
Catheter-associated infections will be compared at the initiation of the project and at the end
Method of measurement
Infection cases will recorded by personnel with checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients admitted to the general intensive care unit who will have a central catheter for at least 48 hours and will receive standard care along with routine care.
Category
Treatment - Other
2
Description
Control group: 30 patients admitted to the intensive care unit of brain surgery who will have a central catheter for at least 48 hours and will receive only routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Behrouz Naghili
Street address
Daneshghah St. Emamreza Hospital - Infectious Diseases Department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 5411
Email
Naghili_b@ yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahabi
Street address
Daneshghah St. Emamreza Hospital - Infectious Diseases Department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 5411
Email
Naghili_b@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Behrouz Naghli
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Daneshghah St. Emamreza Hospital - Infection Diseases Department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 5411
Email
Naghili_b@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behrouz Naghili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Daneshghah St. Emamreza Hospital - Infection Diseases Department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 5411
Email
Naghili_b@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Abbasi
Position
Infection control nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Daneshgha St. Emamreza Hospital - Infection Control Department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3987
Email
Abbasi.zahra93@yahoo.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
Undecided - It is not yet known if there will be 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
En In adress: RDCC.tbzmed.ac.ir
When the data will become available and for how long
Every time
To whom data/document is available
Every one
Under which criteria data/document could be used
Modeling of the subject and method is allowed
From where data/document is obtainable
Send an email to naghili_b@yahoo.com or visit RDCC.tbzmed.ac.ir.
What processes are involved for a request to access data/document
Send an email to naghili_b@yahoo.com or visit RDCC.tbzmed.ac.ir.