Evaluating the effect of early deflation of Trans Radial Band on vascular outcome after transradial coronary angiography in Alzahra hospital in Shiraz 2020
1- Determination and comparison of the effect of routine and early trans radial band evacuation on pain in patients undergoing coronary angiography by radial artery.
2- Determination and comparison of the effect of routine and early trans radial band discharge on hematoma of patients undergoing coronary angiography via radial artery.
3. Determination and comparison of the effect of routine and early trans radial band discharge on radial artery occlusion of patients undergoing coronary angiography via radial artery .
Design
The clinical trial has two intervention and control groups, simple randomization. 70 sample numbers
Settings and conduct
Heart Hospital
Participants/Inclusion and exclusion criteria
1-Men and women 18 years and older
2- Indication of diagnostic angiography, non-emergency treatment, and radial artery prescribed by a physician.
3-Any unexpected condition can lead to disruption of the care process such as myocardial infarction.
4- High levels of consciousness due to hypotension or bleeding
5- Bleeding leads to surgeon intervention
6- Acute and chronic kidney disease
Intervention groups
There will be two groups of control and control in this study. In the control group, The ventilation protocol in this group is the same as the usual protocol in the angiography department. In the control group, after angiography and emptying the sheet and closing the trans radial band, the doctor slowly injected 20 to 25 cc of air into the trans radial band cuff, and after an hour and a half of emptying the cuff again, the same volume of air was evacuated to establish Homeostasis will be returned to the cuff and after 15 to 30 minutes the discharge process will be performed as usual.
Main outcome variables
Hematoma - Radial artery obstruction - Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100919004775N13
Registration date:2020-09-18, 1399/06/28
Registration timing:prospective
Last update:2020-09-18, 1399/06/28
Update count:0
Registration date
2020-09-18, 1399/06/28
Registrant information
Name
Zinat Mohebbi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
zmohebi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of early deflation of Trans Radial Band on vascular outcome after transradial coronary angiography in Alzahra hospital in Shiraz 2020
Public title
effect of early deflation of Trans Radial Band on vascular outcome after transradial coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women 18 years and older
Indication of diagnostic angiography, non-emergency treatment, and through the radial artery, as recommended by the physician.
Exclusion criteria:
Any unexpected condition can lead to disruption of the care process such as myocardial infarction
Bleeding leads to surgeon intervention
Acute and chronic kidney disease
vascular problems (burger, diabetes)
Acute and chronic liver disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be the permutation block method in that A represents the person receiving the intervention and B represents the person who does not receive the intervention.
This method is performed by considering 4 blocks so that the total number of 4 permutations is equal to 6.
(6 blocks including: ABAB, AABB, BABA, BBAA, ABBA and BAAB)
How to use the table of random numbers is that the starting point is selected randomly and 35 numbers are selected randomly (row or column) and the permutation assigned to each number is noted (the order of placement of permutations next to each other in order of Will be left to right) and how to allocate a total of 70 people to 2 groups A, B will be specified.
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 Shiraz University of Medical Sciences
Street address
Ferdowsi Street - Sixth Alley
City
Shiraz
Province
Fars
Postal code
7135855975
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.SUMS.REC.1399.298
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hematoma
Timepoint
Once every 15 minutes
Method of measurement
By Easy Scale
2
Description
pain
Timepoint
Once every 15 minutes
Method of measurement
pain assessment tool
3
Description
Obstruction
Timepoint
Once every 15 minutes
Method of measurement
Pulse oximeter - Allen test
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the first observation of the control and control groups will be excluded. 35 people are considered for each group. In the control group, after angiography and removal of the sheet and closure of the trans radial band at the puncture site, the physician will inject 20 to 25 cc of air inside the trans radial band cafe. The cuff drain protocol in this group will be 5 thirty years after one and a half hours every quarter hour. At time zero, two hours, four hours, six hours after the sheet was removed in the hand undergoing angiography, hematoma and pain and obstruction were adjusted with the Esay scale to collect the horizontal line hematoma, which shows no need from zero to ten. Pain and pain are considered and the use of Allen test and pulse oximetry for obstruction is examined.
Category
Behavior
2
Description
In this study, the first two observations of each of the control and control groups will be discarded. 35 people are considered for each group. In the control group, the cuff evacuation protocol is the same as the usual protocol in the angiography department.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Heart Hospital in Shiraz
Full name of responsible person
Marjan Karami Khairabad
Street address
Valiasr Street
City
Shiraz
Province
Fars
Postal code
32220078
Phone
+98 71 3222 0078
Email
marjankarami60@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Street address
Zand St. - Central Building of Shiraz University of Medical Sciences - 7th floor - Vice Chancellor for Research and Technology
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 8232 3571
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marjan Karami Khairabad
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdowsi street
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
3567978
Phone
+98 71 3222 0078
Email
marjankarami60@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Assistant Professor of Internal Surgery Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sadra - Danesh Blvd. - Eram St. - Farhang St. in front of Farhang 3
City
Shiraz
Province
Fars
Postal code
7199414477
Phone
26033641
Email
Mohebbi04@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Assistant Professor of Surgical Internal Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sadra - Danesh Blvd. - Eram St. - Farhang St. in front of Farhang 3
City
Shiraz
Province
Fars
Postal code
7199414477
Phone
+98 26 0336 4171
Email
MOhebbi04@ 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
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
Information on the impact of the secondary outcome on the main outcome is published.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Participants in research and hospitals
Under which criteria data/document could be used
To participants if they remain in the research until the last stage
From where data/document is obtainable
Call 09173421740 or send an email to marjankarami60@gmail.com.
What processes are involved for a request to access data/document
By referring and sending a request to the email marjankarami60@gmail.com