Determination of the effect of rewarming on hemodynamic parameters and cognitive state in patients after open heart surgery
Design
In this clinical trial, single blind, with two parallel randomized groups, patients who are candidates for open-heart surgery were selected through convenient sampling and were divided into two control(n=40) and intervention(n=40) groups through block randomization (block size of 4).
Settings and conduct
The intervention will begin after entering the patient to the ICU with an electric blanket. Warming will last until the patient's body temperature reaches a normothermic level(37-37.5). The control group will receive routine care.Participant and the person who will analyses the data are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent, MMSE score of more than 24 at beginning, candidates for elective Open-Heart surgery, Not having Intra-Aortic Balloon Pump before surgery.
Exclusion criteria: Prolongation of intubation (more than 12), opened chest for postoperative reasons, having intra-aortic balloon after surgery, post-operative re-intubation, aneurysm or aortic dissection surgery, death, return to the operating room, prolongation of surgery(more than 5), emergency open heart surgeries
Intervention groups
The intervention is rewarming the patients by electric blanket after open heart surgery until the body temperature reaches to 37-37.5.Routine care is done in the control group .
Main outcome variables
Heart rate; systolic blood pressure; diastolic blood pressure; mean arterial pressure; central venues pressure; drainage; urinary output;cognitive state
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100124003146N8
Registration date:2019-10-19, 1398/07/27
Registration timing:registered_while_recruiting
Last update:2019-10-19, 1398/07/27
Update count:0
Registration date
2019-10-19, 1398/07/27
Registrant information
Name
Ismail Azizi-Fini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
azizi-es@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of rewarming on hemodynamic parameters and cognitive state in patients after open heart surgery
Public title
The effect of rewarming on hemodynamic parameters and cognitive state in patients after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent for participating in study
Gaining MMSE score of more than 24 at the beginning of the study
Patients candidate for elective Open-Heart surgery
Not having Intra-Aortic Balloon Pump before the surgery
Exclusion criteria:
Prolongation of intubation (more than 12 hours) for respiratory problems
Opened chest for postoperative reasons
Having Intra-Aortic Balloon Pump after the surgery
post-operative re-intubation
Patients who underwent the surgery of aneurysm or dissection of aorta
patient death
Return to operating room for any reason
Prolonged surgery for more than 5 hours
Patients undergoing emergency open heart surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly assigned to experimental and control groups by block randomization (via software) with 4 blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because patients have low level of consciousness and are intubated, they are not aware of the type of intervention and are blind. On the other hand, the person who analyzes the results of the study is not aware of the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Kashan University of Medical Sciences
Street address
5th kilometer Qotb Ravandi blouvar
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.016
Health conditions studied
1
Description of health condition studied
Hemodynamic parameters of the patient undergoing open heart surgery- cognitive state of the patient undergoing open heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mean arterial pressure
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention)
Method of measurement
monitor
2
Description
Systolic blood pressure
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention)
Method of measurement
monitor
3
Description
Diastolic blood pressure
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention)
Method of measurement
monitor
4
Description
Central venous pressure
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention)
Method of measurement
monitor
5
Description
Heart rate
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention)
Method of measurement
monitor
6
Description
temperature
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention)
Method of measurement
temperature probe of monitor
7
Description
Urine output
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every hour (for 4 hours after the intervention)
Method of measurement
urinary bag
8
Description
drainage
Timepoint
Before the intervention at the time of entering of the patient to the ICU, every hour (for 4 hours after the intervention)
Method of measurement
Drainage bottle
9
Description
cognitive state
Timepoint
Before the intervention and one week after surgery
Method of measurement
MMSE questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of a warm mattress at the time of entering the patient to intensive care unit until the body temperature reaches 37 ° C after open heart surgery.in this method , for warming the patient, E U 133 (Electric Under blanket with heating) will be used which has the power of W75. the size of the product is about 150* 80 cm . temperature setting has three level index , which is switched off automatically after three hours , warms fast and the most heat is in the foot
Category
Treatment - Devices
2
Description
Control group: control group will receive the routine care after open heart surgery.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Somayeh Hajijafari
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
s.h.jaafari95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Esmail Azizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0022
Email
azizi_es@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ismail Azizi-Fini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0022
Email
azizi_es@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Somayeh Hajijafari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
s.h.jaafari95@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available