Protocol summary

Study aim
Comparison of the success rate of closing two tourniquets and one tourniquet in peripheral venous line access in patients of the emergency department of Vasi Hospital in Sabzevar city.
Design
Clinical trial with a control group, with parallel groups, double-blind,There is not blinding , phase 3 on 100 patients, randomization load using permutation blocks
Settings and conduct
After the approval of the project and obtaining the code of ethics and IRCT, we referred to the emergency department of Vasei Hospital in Sabzevar and selected the patients who referred to the emergency department and met the study inclusion criteria using the convenience method. The written informed consent of patients was obtained. Then, the patient's demographic information questionnaire and clinical trial application checklist were completed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. The need to establish a venous line, 2. Having consent to participate in the study, 3. The age of the studied patients is limited to 20-50 years 4. Pregnancy (other than absence, patients are considered high risk group) Exclusion criteria: having a life-threatening condition (emergency), edema, obesity, peripheral vascular disease, Raynaud's phenomenon, scleroderma, sickle cell anemia, methemoglobinemia, patients with a history of any drug allergy and underlying diseases, including cardiovascular , high blood pressure, coagulation disorder, excessive bleeding, Hb less than 10, kidney failure, drug abuse and skin infection, and patients are less than 20 years old and more than 50 years old.
Intervention groups
Intervention group: 50 patients with two tourniquets Control group: 50 patients with a tourniquet
Main outcome variables
success in accessing the peripheral venous line

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220713055459N1
Registration date: 2023-04-06, 1402/01/17
Registration timing: prospective

Last update: 2023-04-06, 1402/01/17
Update count: 0
Registration date
2023-04-06, 1402/01/17
Registrant information
Name
Vahid Deldar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5456 3515
Email address
vahiddeldar1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of closing two tourniquets versus closing one tourniquet on the success of access to a peripheral venous line in emergency department patients
Public title
The effect of closing one and two tourniquets on the success of peripheral venous access
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The need to establish a venous line Consent to participate in the study The age of the studied patients is limited to 20-50 years Pregnancy (other than absence, patients are considered high risk group) Consciousness of the patient
Exclusion criteria:
Having a life-threatening condition (emergency) Edema Excessive obesity Peripheral vascular disease Raynaud's phenomenon Scleroderma Sickle cell anemia methemoglobinemia Patients with a history of any drug allergy and underlying disease, including cardiovascular Hypertension Coagulation disorder Hemoglobin less than 10 Renal failure Drug abuse skin infection Age limit (at least 20 years old and more than 50 years old)
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Using the permuted block technique, the patients were divided into two groups of one tourniquet and two tourniquets. In this way, each block of n=4 was allocated to the intervention group of n=2 and the control group of n=2. A total of six blocks in different states were obtained and each block was numbered with a number. The blocks of n=4 were selected based on the table of random numbers until the sample size reached n=100. Finally, 50 patients were in the control group and 50 patients were in the intervention group. This was repeated until the end of sampling. In allocation concealment technique, the participants themselves were not aware of the type of educational intervention and the data analyst was not aware of the group due to the coding of the data. To avoid bias, sampling was done by an officially employed male nurse with at least two years of clinical work experience.
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 Sabzevar University of Medical Sciences
Street address
Sabzevar Univercity Of Medical Sciences,Asad Abadi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2022-07-12, 1401/04/21
Ethics committee reference number
IR.MEDSAB.REC.1401.021

Health conditions studied

1

Description of health condition studied
ِDouble Tourniquetes Technique
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Success in peripheral venous line access
Timepoint
Immediately
Method of measurement
Clinical results registration checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Using double tourniquets to access the peripheral venous lines
Category
Treatment - Devices

2

Description
Control group: Using single tourniquets to access the peripheral venous lines
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Vahid Deldar
Street address
Vasei Hospital,Asadabadi Ave,Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
waseehospital@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
MohammadHosein Saghi
Street address
Sabzevar University Of Medical Sciences,َAsad Abadi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1000
Email
info@medsab.ac.ir
Web page address
https://www.medsab.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Vahid Deldar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
ImamReza Blvd
City
Taybad
Province
Razavi Khorasan
Postal code
9593119187
Phone
009854563515
Email
vahiddeldar1375@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Abdolghader Assarroudi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Asad Abadi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8439
Fax
+98 51 4426 4462
Email
ghaderassar@yahoo.com
Web page address
http://isid.research.ac.ir/Abdolghader_Assarroudi

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Vahid Deldar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
ImamReza Blvd
City
Taybad
Province
Razavi Khorasan
Postal code
9593119187
Phone
009854563515
Email
vahiddeldar1375@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the information, it will be sent to them confidentially if requested by the journal or the reviewers of the journal or other competent legal authorities.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Due to the confidentiality of the information, it will be sent to them confidentially if requested by the journal or the reviewers of the journal or other competent legal authorities.
When the data will become available and for how long
2023-2026
To whom data/document is available
Scientific institutions and people working in scientific and academic institutions
Under which criteria data/document could be used
Use of study results - perform secondary analysis
From where data/document is obtainable
ghaderassar@yahoo.com
What processes are involved for a request to access data/document
Send an email to the study supervisor
Comments
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