Comparison the Effect of Continuous and Intermittent Flushing on Maintaining Patency of the Arterial Complications after Coronary Artery Bypass Surgery
This study is a randomized clinical trial with two-group that conducted on the patients who underwent CABG procedures off pump and hospitalized in intensive care unit open heart of Imam Reza hospital in Mashhad is done. The aim of this study is evaluation the efficacy of cleaning continuous and intermittent on maintaining openness and complications of arterial line. The main outcomes is time openness artery catheter, blocking the artery catheter, and incidence of complications (bleeding, hematoma) at the arterial catheter every 3 hours from the time of acceptance of the open heart ICU. Sample size is considered 30 patients in each group. In the intervention group washed artery catheter in a continuous manner using a cuff transfusion so that saline containing heparin in a pressure cuff is placed 300 mmHg and 3 ml of solution heparin infused in the catheter per hour. Catheter patency will be assessed with blood backward into the catheter and complications, including bleeding and hematoma checked every 3 hours. The result is entered in the checklist. In the control group artery catheter intermittent is flushed by a syringe 5 ml with 5 cc of saline with heparin every 3 hours. Complications of catheter and catheter patency and will be accessed similar intervention group and recorded in the checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050427741N1
Registration date:2016-08-09, 1395/05/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-09, 1395/05/19
Registrant information
Name
Sedigheh Arta
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32566747
Email address
artas1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Continuous and Intermittent Flushing on Maintaining Patency of the Arterial Complications after Coronary Artery Bypass Surgery
Public title
Effect of Arterial Catheter Irrigation on the rate of Obstruction and its Complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Have consent to participate in the study; coronary artery bypass surgery is located off pomp; have artery catheter; vascular disorders do not have; have been 18-70 years old; preoperative coagulation disorders have (Pt less than 13 seconds and ptt less than 45 seconds).
Exclusion criteria: Unwillingness to continue to participate in the study; The incidence of coagulation disorders and testing ptt-pt is disrupted (According to the listed criteria); artery catheter is removed for any reason.
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:
60
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
Ethics committee of Mashhad University of Medical Sciences
Street address
University of Medical Sciences Mashhad, Vice chancellor for research, Ghoraishy Building, University St, Mashhad
City
Mashhad
Postal code
Approval date
2016-06-18, 1395/03/29
Ethics committee reference number
IR.MUMS.REC.1394.1271
Health conditions studied
1
Description of health condition studied
Obstruction and Complications of Arterial Line
ICD-10 code
Y61.6
ICD-10 code description
During aspiration, puncture and other catheterization
Primary outcomes
1
Description
Obstruction
Timepoint
Every 3 hours
Method of measurement
Back arterial catheter aspiration and view the monitor arterial pressure curve
Secondary outcomes
1
Description
bleeding
Timepoint
Every 3 hours
Method of measurement
Find bleeding at the insertion site
2
Description
Hematoma
Timepoint
Every 3 hours
Method of measurement
Find hematoma in the soft tissue surrounding the artery catheter
Intervention groups
1
Description
Wash the intervention group artery catheter for continuous infusion using 3 ml per hour with heparin saline done.
The control group artery catheter with a syringe 5 ml every 3 hours 5 cc of saline Heparin alternate method and catheter patency and complications similar groups in the Czech list will be recorded every 3 hours.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyed Reza Mazlom
Street address
Open Heart Department, Imam Reza Hospital, Ebne Sina St, Imam Reza Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences Mashhad, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
University of Medical Sciences Mashhad, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Mashhad, Vice chancellor for research
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
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Sedigheh Arta
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads Mashhad
City
Mashhad
Postal code
Phone
+98 51 3256 6747
Fax
Email
artas1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Seyed Reza Mazlom
Position
Assistant Professor in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Mazlomr[at]mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Sedigheh Arta
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
9157997714
Phone
+98 51 3256 6747
Fax
Email
Artas1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)