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The Comparative Study of the Effects of Sand Bag Keeping Time and Changing Body Position on Acute Complications of Coronary Angiography.

Protocol summary

Summary
This study aimed to evaluate the effect of duration of sandbag and change position on the acute complications of coronary angiography in patients referred to angiography Tohid Hospital in Sanandaj, 1394 will be conducted. This triple blind clinical trial with a sample size of 75 patients undergoing coronary angiography, a 3-block design and randomized into 3 groups: control, sandbag’s intervention group and Changing body Position’s intervention group will be carried out. patients in the control group, will receive routines care include of 8 hours motionless in supine position, with head angle of zero degrees, rest in bed and preserving a 4 kg sandbag on the site of catheter insertion for 6 hours. patients in sandbag’s intervention group will receive routines care except that in the third hour after entering to the heart ward, sandbag will be removed from the position. patients in Changing body Position’s intervention group will receive routines care except that the following positions during bed rest will be applied. During the first and second hours supine position and head angle of zero degrees, during the third and fourth positions supine head angle of 45 degrees, during the fifth and sixth hours left and right latera position with head angle of 15 degrees and in the seventh and eighth in the sitting position will be cared for. The acute angiographic complications in three groups, including urinary retention, bruising, thrombosis, bleeding, hematoma, back pain, groin pain, the the discomfort in 0, 3, 6, 8 and 24 hours after the entering the patient to the heart ward will be studied and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091424018N1
Registration date: 2015-11-14, 1394/08/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-14, 1394/08/23
Registrant information
Name
Parvin Mahmoodi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 0414
Email address
mahmoodi.parvin@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Study of the Effects of Sand Bag Keeping Time and Changing Body Position on Acute Complications of Coronary Angiography.
Public title
Evaluation of Coronary Angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: under non-emergency catheterization; age between 18-65 years; blood pressure less than 100/180 mmHg; the absence of active bleeding disorders; prothrombin time less than 16 seconds and time; Partial thromboplastin less than 90 seconds; no history of diabetes with disabilities; consent to participate in the study; angiography via the femoral artery; arterial puncture for the route only once; no DVT before the procedure; treatment with thrombolytic drugs and anticoagulant (taking warfarin); taking pain medication before the procedure; lack of peripheral vascular disease; no history of urinary problems; lack of sensitivity to contrast; no drug addiction; lack of chronic low back pain lack of blood and liver disease will be. Exclusion criteria: active bleeding from the catheter entry with hemodynamic impairment and the need for blood transfusion; blood coagulation disorders; history of chronic low back pain; the need for cardiopulmonary resuscitation during angiography; chest pain with ECG changes; non-invasive blood pressure (NIBP) systolic or diastolic over and over mmHg 180 mmHg 100; disability and impaired level of consciousness in such a way that the patient is able to transform the work; rupture of the femoral artery during angiography; after a dangerous rhythm disorder Angiography; heparin injection during or after the procedure; the patient's hemodynamic status was while studying will be unhappy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences,sanandaj, kurdistan
City
sanandaj
Postal code
Approval date
2015-09-30, 1394/07/08
Ethics committee reference number
MUK.REC.1394.194

Health conditions studied

1

Description of health condition studied
complication of cronary angiography
ICD-10 code
I70.8
ICD-10 code description
Atherosclerosis of other arteries( coronary arteries)

Primary outcomes

1

Description
bleeding
Timepoint
at 0, 3, 6, 8 and 24 hours after angiography
Method of measurement
Measurement scales with a sensitivity of 0.1 g

2

Description
hematoma
Timepoint
at 0, 3, 6, 8 and 24 hours after angiography
Method of measurement
with Trans Parente and graph paper

3

Description
bruise
Timepoint
at 0, 3, 6, 8 and 24 hours after angiography
Method of measurement
with Trans Parente and graph paper

4

Description
pain( include of back pain and groin pain)
Timepoint
at 0, 3, 6, 8 and 24 hours after angiography
Method of measurement
NRS

5

Description
urinary retention
Timepoint
at 0, 3, 6, 8 and 24 hours after angiography
Method of measurement
Based on asking from the patient

6

Description
convenience
Timepoint
at 0, 3, 6, 8 and 24 hours after angiography
Method of measurement
VAS

7

Description
thrombosis
Timepoint
at 0, 3, 6, 8 and 24 hours after angiography
Method of measurement
The sensory and motor symptoms, absence of peripheral pulse, the white appearance and painful physical examination

Secondary outcomes

empty

Intervention groups

1

Description
control group: patients in the control group, will receive routines care include of 8 hours motionless in supine position, with head angle of zero degrees, rest in bed and preserving a 4 kg sandbag on the site of catheter insertion for 6 hours.
Category
Prevention

2

Description
sandbag’s intervention group: patients in sandbag’s intervention group will receive routines care except that in the third hour after entering to the heart ward, sandbag will be removed from the position.
Category
Prevention

3

Description
Changing body Position’s intervention group: patients in Changing body Position’s intervention group will receive routines care except that the following positions during bed rest will be applied. During the first and second hours supine position and head angle of zero degrees, during the third and fourth positions supine head angle of 45 degrees, during the fifth and sixth hours left and right latera position with head angle of 15 degrees and in the seventh and eighth in the sitting position will be cared for.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Parvin Mahmoodi
Street address
number7, Diman 4 alley, Hazhar street, Andishe town, Janbazan blv,Sanandaj,Kurdistan
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Parvin Mahmoodi
Street address
Number7,Diman 4 alley ,Hazhar street, Andishe town, Janbazan blv,Sanandaj,Kurdistan
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Sina Valiee
Position
Ph.D of Nursing Education
Other areas of specialty/work
Street address
Number 4, Negin alley, Keshavarz town, Sanandaj
City
Sanandaj
Postal code
Phone
00
Fax
Email
sinavaliee@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Parvin Mahmoodi
Position
MS Student of Medical Surgical of Nursing
Other areas of specialty/work
Street address
Number7,Diman 4 alley, Hazhar street, Andishe town, Janbazan blv, Sanandaj, Kurdistan
City
Sanandaj
Postal code
6616814915
Phone
+98 87 3328 0414
Fax
+98 87 3328 1240
Email
mahmoodi.parvin@gmail.commahmoodi.parvin@muk.ac.irmahmoodi.parvin@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Parvin Mahmoodi
Position
MS Student of Medical Surgical of Nursing
Other areas of specialty/work
Street address
Number7,Diman 4 alley ,Hazhar street, Andishe town, Janbazan blv,Sanandaj,Kurdistan
City
Sanandaj
Postal code
6616814915
Phone
+98 87 3328 0414
Fax
+98 87 3328 0414
Email
mahmoodi.parvin@gmail.commahmoodi.parvin@muk.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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