The effect of using sandbags and early mobilization in reducing the incidence of the hematoma and Subclinical deep vein thrombosis in patients undergoing cardiac radiofrequency catheter ablation .
The objective of this study is to assess of “The effect of using sandbags and early mobilization on hematoma and Sub clinical deep vein thrombosis of patients undergoing cardiac radio-frequency catheter ablation”. Inclusion criteria is candidates for Treatment of cardiac dysrhythmia using cardiac radio-frequency catheter ablation. Exclusion criteria is included Existence of atrial fibrillation, history of deep vein thrombosis, under treatment with thrombolytic drugs, Extensive bleeding or any other complication such as dysrhythmia during and after the radio-frequency catheter ablation procedure. The study population included patients undergoing cardiac radio-frequency catheter ablation referred to Shiraz University of Medical Sciences hospitals and the sample size is 225 people. The intervention consisted of using sandbags on the groin and early mobilization of patients. The intervention start after admission the patients undergoing cardiac radio-frequency catheter ablation in the ward and follow up them until discharge from the hospital (Usually 24 hours). The expected primary result of the study is absence of the hematoma and reduce the incidence of Sub clinical deep vein thrombosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011631992N1
Registration date:2017-03-20, 1395/12/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-20, 1395/12/30
Registrant information
Name
Mehdi Abbasi Jondani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 4654 3029
Email address
stud1270652427@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using sandbags and early mobilization in reducing the incidence of the hematoma and Subclinical deep vein thrombosis in patients undergoing cardiac radiofrequency catheter ablation .
Public title
The effect of using sandbags and early mobilization on clot formation after ablation catheter removal.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: candidates for Treatment of cardiac dysrhythmia using cardiac radiofrequency catheter ablation; willing to have cooperation in the project; radiofrequency catheter ablation through a vein procedure; age range should be between 18-70 years; systolic blood pressure less than 190 and diastolic blood pressure should be less than 110 mmHg. Exclusion criteria: Unwillingness of participants to continue with the project; Existence of atrial fibrillation; Existence of bleeding disorder; history of deep vein thrombosis before the procedure; cardiac catheterization history over the past month; existence of risk factors causing the increase of deep vein thrombosis incidence such as complete bed rest; loss of consciousness; Existence of advanced heart failure (grade 3 or 4); receiving sedatives during and after the radiofrequency catheter ablation procedure (to avoid having a problem from getting out of bed); treatment with thrombolytic drugs under medical supervision; Extensive bleeding or any other complication such as dysrhythmia during and after the radiofrequency catheter ablation procedure.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
225
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shiraz University of Medical Science
Street address
Headquarters of Shiraz University of Medical Science, Zand st
City
Shiraz
Postal code
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.SUMS.REC.1395.199
Health conditions studied
1
Description of health condition studied
cardiac arrhythmias
ICD-10 code
I49
ICD-10 code description
Other cardiac arrhythmias
Primary outcomes
1
Description
Hematoma
Timepoint
Immediately after the departure of catheter sheaths and admission the patients in the ward and follow up them until discharge from the hospital
Method of measurement
Ruler of two-dimensional designed
2
Description
Subclinical deep vein thrombosis
Timepoint
Immediately after discharge (24 hours after admission)
Method of measurement
Doppler ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group 1, patients will receive in addition to routine care, intervention using the 2-pound sandbags for 2 hours on the catheter site will be on the groin.
Category
Other
2
Description
The intervention group 2, in addition to usual care, after 4 hours of bed rest, will be out of bed. That first sitting bedside and then monitoring the vital signs and blood pressure and pulse stability and the absence of complications such as bleeding and hematoma during 4 hours of bed rest, the patients will be out of bed and will walk.
Category
Other
3
Description
In the control group, the patients after radiofrequency catheter ablation procedure, will receive usual care which includes complete bed rest in the supine position in the bed for 6 to 8 hours without shaking and bending and straightening the involved leg. Also in the first, the vital signs every 15 minutes to 1 hour, then every 30 minutes to 1 hour and then every 4 hours until discharge will be monitored and recorded in the form.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi hospital
Full name of responsible person
Mehdi Abbasi Jondani
Street address
Shiraz, Fars
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Headquarters of Shiraz University of Medical Science, Zand st
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?