1. Home
  2. Approved trials
  3. » فارسی

Designing and manufacturing of an inflatable thigh strap and evaluating its effectiveness on hemostasis during sheet removal and prevention of complications after transfemoral coronary angiography in patients referring to hospital.

Protocol summary

Study aim
This study was conducted with the aim of designing and manufacturing an inflatable thigh strap and determining its effectiveness in preventing the complications of sheet removal after transfemoral coronary angiography.
Design
Clinical trial with a control group.not blindet,randomized
Settings and conduct
This randomized clinical trial was conducted in 2021. 80 patients undergoing elective transfemoral coronary angiography referred to 502 Heart and Vascular Hospital in Tehran were included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria included being alert, not suffering from hemophilia and coagulation disorders, age between 45 and 70 years, candidate for femoral angiography. The exit criteria are also: refusal to continue cooperation, the occurrence of complications such as bleeding, hematoma, and abnormal pain during the intervention, and use of painkillers or narcotics before, during, and after transfemoral coronary angiography.
Intervention groups
In the test group, an inflatable thigh starp was used to maintain hemostasis and prevent bleeding and hematoma immediately after the removal of the femoral sheath and hemostasis by hand in the Catheterization Laboratory by a trained nurse according to the protocol determined based on point pressure at the puncture site of the artery, the femoral was closed. The tourniquet was left in place for 4 to 6 hours and then opened. All procedures were performed under the supervision of a physician.
Main outcome variables
inflatable thigh starp, groin pain, back pain, feeling comfortable, hematoma, bleeding, leg pain, urinary incontinence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200410047011N2
Registration date: 2022-12-13, 1401/09/22
Registration timing: retrospective

Last update: 2022-12-13, 1401/09/22
Update count: 0
Registration date
2022-12-13, 1401/09/22
Registrant information
Name
Hojjat Niknam Sarabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8830 7020
Email address
offface92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
2020-11-19, 1399/08/29
Actual recruitment end date
2021-05-14, 1400/02/24
Trial completion date
2021-05-14, 1400/02/24
Scientific title
Designing and manufacturing of an inflatable thigh strap and evaluating its effectiveness on hemostasis during sheet removal and prevention of complications after transfemoral coronary angiography in patients referring to hospital.
Public title
Designing and manufacturing of an inflatable thigh strap and evaluating its effectiveness on hemostasis during sheet removal and prevention of complications after transfemoral coronary angiography.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being alert not suffering from hemophilia and coagulation disorders age between 45 and 70 years candidate for femoral angiography
Exclusion criteria:
refusal to continue cooperation the occurrence of complications such as bleeding hematoma, and abnormal pain during the intervention use of painkillers or narcotics before, during, and after transfemoral coronary angiography.
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 patients were included in the study by available sampling method and were divided into experimental and control groups based on the day of visit by coin toss. In this way, the patients who were visited on Sundays were included in the experimental group and they used an inflatable thigh strap, and the patients who visited on Mondays were in the control group and used sandbags according to the hospital routine.
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
Army University of Medical Sciences
Street address
Etemadzade st, Ave Fatemi, TEHRAN, IRAN
City
Tehran
Province
Tehran
Postal code
1613917117
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.AJAUMS.REC.1399.133)

Health conditions studied

1

Description of health condition studied
patients with coronary artery disease undergoing transfemoral coronary angiography
ICD-10 code
Y84.0
ICD-10 code description
Cardiac catheterization as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Primary outcomes

1

Description
Groin pain: groin pain refers to a feeling of discomfort in the area where the abdomen ends and the legs begin
Timepoint
Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications.
Method of measurement
The Visual Analog Scale will be used to measure groin pain. The Visual Analog Scale is used to measure pain. The visual analog scale is the evaluation of pain intensity as a 10 cm horizontal line numbered from 0 to 10 (zero indicates the absence of pain and 10 indicates the most severe pain possible)

2

Description
Hematoma: Localized bleeding outside the blood vessels, which occurs due to illness or trauma, including injury or surgery, and may lead to continued bleeding from broken capillaries. The hematoma is benign and initially spreads as fluid between tissues, including the interstitial sacs, which may coagulate and solidify in the blood vessels before reabsorption.
Timepoint
Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications.
Method of measurement
The Christensen scale was used to measure hematoma.

3

Description
leg pain: Prickle, cramping, fatigue and sometimes burning in the legs caused by poor blood circulation in the arteries of the legs
Timepoint
Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications.
Method of measurement
The Visual Analog Scale will be used to measure leg pain. The Visual Analog Scale is used to measure pain. The visual analog scale is the evaluation of pain intensity as a 10 cm horizontal line numbered from 0 to 10 (zero indicates the absence of pain and 10 indicates the most severe pain possible).

4

Description
Bleeding: Any bleeding that comes out of the circulatory system due to damage to the blood vessels is called bleeding. Bleeding may be due to vascular disorders, platelets, coagulation factors, coagulation inhibitors, exacerbation of fibrinolysis, or a combination of these factors. Typically, a healthy person can lose 10 to 15% of their total blood volume without serious medical problems. Tolerate.
Timepoint
Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications.
Method of measurement
En The amount of blood loss will be calculated based on the amount of bleeding based on the number of blood-soaked gases. Given that each 4 in 4 blood gasses in blood is about 10 ml of blood, then the amount of bleeding during 6 hours calculated by multiplying the number of gases collected in 10 Will take.

5

Description
prothrombin time (PT), Partial thromboplastin time (PTT), international normalized ratio (INR)
Timepoint
Before intervention
Method of measurement
Laboratory indicators were measured in the hospital laboratory.

6

Description
Hemodynamic indicators (systolic and diastolic blood pressure, temperature, respiratory rate, heart rate, and arterial oxygen saturation (Sao2))
Timepoint
Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications.
Method of measurement
The hemodynamic indicators of the patients were recorded by the monitoring device. The temperature was measured with a thermometer.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the test group, an inflatable thigh starp was used to maintain hemostasis and prevent bleeding and hematoma immediately after the removal of the femoral sheath and hemostasis by hand in the Catheterization Laboratory by a trained nurse according to the protocol determined based on point pressure at the puncture site of the artery, the femoral was closed. The tourniquet was left in place for 4 to 6 hours and then opened. All procedures were performed under the supervision of a physician.
Category
Treatment - Devices

2

Description
Control group: according to the hospital routine, a sandbag was used instead of an inflatable thigh strap. The weight of the sandbag was 2.5 kg, which was placed in the puncture site of the femoral artery for 6 hours. In all stages, patients of the control group had to keep their legs straight. When the patient was in a semi-sitting position, a pillow was placed on the patient’s back.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Army 502 Hospital
Full name of responsible person
Hojjat Niknam Sarabi
Street address
Army 502 Haspital, Taleghani Ave, Junc Bahar North st, TEHRAN, IRAN
City
Tehran
Province
Tehran
Postal code
1571755511
Phone
+98 21 8830 7020
Fax
+98 21 8830 8109
Email
Offface92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Prof. Zahra Farsi
Street address
Aja Nursing School, Kaj st., Shariati st., TEHRAN, IRAN
City
Tehran
Province
Tehran
Postal code
1613917117
Phone
+98 21 7750 0404
Email
zahrafarsi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Hojjat Niknam Sarabi
Position
Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Army 502 Haspital, Taleghani Ave, Junc Bahar North st, TEHRAN, IRAN
City
Tehran
Province
Tehran
Postal code
1571755511
Phone
+98 21 8830 7020
Fax
+98 21 8830 8109
Email
Offface92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hojjat Niknam Sarabi
Position
Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Army 502 Haspital, Taleghani Ave, Junc Bahar North st, TEHRAN, IRAN
City
Tehran
Province
Tehran
Postal code
1571755511
Phone
+98 21 8830 7020
Fax
+98 21 8830 8109
Email
Offface92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hojjat Niknam Sarabi
Position
Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Army 502 Haspital, Taleghani Ave, Junc Bahar North st, TEHRAN, IRAN
City
Tehran
Province
Tehran
Postal code
1571755511
Phone
+98 21 8830 7020
Fax
+98 21 8830 8109
Email
Offface92@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
This study was approved by the Ethics Committee of Aja University of Medical Sciences (code IR.AJAUMS.REC.1399.133). The provisions of the Declaration of Helsinki were observed in this study. Patients entered the study voluntarily and could withdraw from the study whenever they wished. Also, the purpose of the study was explained to the patients and written informed consent was obtained from all patients. The researchers were obliged to ensure that the patients did not suffer physical harm and all possible side effects of the intervention were monitored and, if necessary, appropriate measures were replaced. The confidentiality of all data and the confidentiality of the information sources used were also observed.
When the data will become available and for how long
6 months after printig results
To whom data/document is available
This study was approved by the Ethics Committee of Aja University of Medical Sciences (code IR.AJAUMS.REC.1399.133). The provisions of the Declaration of Helsinki were observed in this study. Patients entered the study voluntarily and could withdraw from the study whenever they wished. Also, the purpose of the study was explained to the patients and written informed consent was obtained from all patients. The researchers were obliged to ensure that the patients did not suffer physical harm and all possible side effects of the intervention were monitored and, if necessary, appropriate measures were replaced. The confidentiality of all data and the confidentiality of the information sources used were also observed.
Under which criteria data/document could be used
This study was approved by the Ethics Committee of Aja University of Medical Sciences (code IR.AJAUMS.REC.1399.133). The provisions of the Declaration of Helsinki were observed in this study. Patients entered the study voluntarily and could withdraw from the study whenever they wished. Also, the purpose of the study was explained to the patients and written informed consent was obtained from all patients. The researchers were obliged to ensure that the patients did not suffer physical harm and all possible side effects of the intervention were monitored and, if necessary, appropriate measures were replaced. The confidentiality of all data and the confidentiality of the information sources used were also observed.
From where data/document is obtainable
Hojjat Niknam Sarabi, +98 9125574438, offface92@gmail.com
What processes are involved for a request to access data/document
Send email to the responsible author, confirmation by authors, confirmation by army univarsity of medical sciences, provide data
Comments
Loading...