Objective: This study aimed to design and implement evidence-based care guidelines for removing arterial sheath in patients undergoing angioplasty of coronary artery.
Patients and Methods: This clinical trial was performed in 200 patients (two groups of 100 patients; age 62.5 ± 10.8 years) from July 2014 to February 2014 in Baqiyatallah University of Medical Sciences (BUMS), Tehran, Iran. First, we designed a five-step guideline for removing the arterial sheath. Then the designed guideline in the current study and the routine guideline were used for removing the arterial sheath in patients in the intervention and the control groups, respectively. Finally, we recorded the effects and outcomes including bleeding, vasovagal, urine retention, and back pain.
inclusion criteria:
patient does not have hemodialysis –
patients who do not require emergency percutaneous Transluminal coronary Angioplasty(PTCA)
exclusion criteria:
patients who for any reason had a sudden increase in serum creatine that were leading to hemodialysis
patients who developed severe hemorrhage in the arterial sheath place and returned to cath lab.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604138650N8
Registration date:2016-06-05, 1395/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-05, 1395/03/16
Registrant information
Name
Abbas Ebadi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6057
Email address
ebadi1347@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatalla University of Medical sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2015-01-30, 1393/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of evidence based practice on outcomes after removal of arterial sheath in patients with angioplasty
Public title
Outcomes of removal of arterial sheath in patients with angioplasty
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:
1- patient does not have hemodialysis
2-patients who do not require emergency percutaneous Transluminal coronary Angioplasty(PTCA)
exclusion criteria:
1- patients who for any reason had a sudden increase in serum creatine that were leading to hemodialysis
2- patients who developed severe hemorrhage in the arterial sheath place and returned to cath lab.
Age
From 42 years old to 89 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The objectives of the study were explained to the patients and informed consent was obtained. Then according to the inclusion criteria, patients were randomly assigned based on random-number table to intervention (n =100) and control group (n=100). Then, in control group according to the conventional methods and in intervention group based on the new designed guideline, removal of the arterial sheath and then outcomes (vasovagal, bleeding, hematoma, urine retention and back pain ) are recorded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics commitee of Baqiyatallah University of Medical sciences
Street address
6th Floor, Nursing Faculty, Baqiyatallah University of Medical Sciences, P.O.Box: 19575174
City
Tehran
Postal code
00982119575174
Approval date
2014-04-30, 1393/02/10
Ethics committee reference number
IR.BMSU.REC.34055904
Health conditions studied
1
Description of health condition studied
Coronary Artery disease
ICD-10 code
I25
ICD-10 code description
ischemic heart disease
Primary outcomes
1
Description
Vasovagal
Timepoint
During and after removal the arterial sheath
Method of measurement
check list
2
Description
Bleeding
Timepoint
ِDuring and after removal the arterial sheath
Method of measurement
check list
Secondary outcomes
1
Description
Hematoma
Timepoint
After removal the arterial sheath
Method of measurement
Check list
2
Description
Urine retention
Timepoint
After removal the arterial sheath
Method of measurement
Check list
3
Description
Back pain
Timepoint
After removal the arterial sheath
Method of measurement
Check list
Intervention groups
1
Description
In the intervention group, removal of the arterial sheath and clinical care were based on the following protocol.
1. Control of ACT in the third hour after angioplasty
2. If ACT was less than or equal to 175, the arterial sheath would be removed by manual compression.
3. Put direct pressure on the arterial sheath insertion site for two to three minutes so that the dorsalis pedis pulse disappears. Then lower the pressure to feel the dorsalis pedis pulse. Continue pressuring until hemostasis (10 to 20 minutes).
4. Put pressure dressing on arterial sheath area by a trained doctor or nurse.
5. Put two sandbags (4 kg weight per bag) on the dressing by nurse
6. Remove the first and the second sandbags two and three hours after removing the arterial sheath, respectively.
7. Patients were out of bed three hours after removal of the arterial sheath in case of no complication.
8. Record outcomes of removal of the arterial sheath in the data record form (all outcomes during the removal and up to one day after that were recorded).
Category
Prevention
2
Description
In control patients, the arterial sheath was removed 4 to 6 hours after angioplasty, and then the manual compression was used for hemostasis. Two 8 kg sandbags compressed the dressing position. The first and second sandbags were removed two hours and 4-6 hours after removing the arterial sheath, respectively. Patients were out of bed 6 hours after removing the arterial sheath. Finally, outcomes of removing the arterial sheath, during this procedure and up to one day after that, were logged in the data record form.