Assessing The Effects Of Mild And Moderate Hypothermia On The Cerebral Oxymetery In Acyanotic Congenital Heart Disease Under The Cardiopulmonary Bypass
The effect of mild to moderate hypothermia on changes in cerebral oxygenation in children undergoing surgery for Acyanotic congenital heart disease
Design
Random; a blind; Quadruple blocks; 64 patients
Settings and conduct
The nasopharyngeal temperature will be maintained above 35 degrees for the time before the onset of cardiopulmonary bypass.For each child, 5 measurements are performed at different intervals: 1- at the time after induction of anesthesia (baseline value), 2- at the time of cooling up to 34 degrees Celsius, 3- at the time of the lowest level of cooling (first group 32 Degrees Celsius), (the second group 28 degrees Celsius), 4-during reheating (above 34 degrees Celsius), 5-after CPB completion.
Participants/Inclusion and exclusion criteria
Inclusion criteria:: children who are candidates for non-cyanotic congenital heart disease surgery; children aged 1 day to 14 years; candidates for open heart surgery under the cardiopulmonary system (CPB); weight range between 5 and 20 kg. Exclusion criteria: history of neurological diseases, liver or kidney failure (creatinine above 2 mg / dL), preoperative anemia; history of cardiopulmonary resuscitation; emergency cardiac surgery, instability of hemodynamic status during the operation and decrease in temperature in the operation below the desired temperature.
Intervention groups
Mild hypothermia (32° C) group; moderate hypothermia (28° C) group.
Main outcome variables
Evaluation of rso2 changes; Evaluation of lactate changes; Percentage of frequency of neurological complications; Evaluation of postoperative intubation duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201217049741N1
Registration date:2021-01-10, 1399/10/21
Registration timing:registered_while_recruiting
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Mehran Jafarian
Name of organization / entity
Shaheed Rajaie Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 3384 9956
Email address
mehran-jafarian@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing The Effects Of Mild And Moderate Hypothermia On The Cerebral Oxymetery In Acyanotic Congenital Heart Disease Under The Cardiopulmonary Bypass
Public title
Assessing The Effects Of Mild And Moderate Hypothermia On The Cerebral Oxymetery In Acyanotic Congenital Heart Disease Under The Cardiopulmonary Bypass
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children 1 day to 14 years old undergoing surgery for Acyanotic congenital heart disease with pulmonary heart bypass
Children weighing 5 to 20 kg
No history of neurological diseases
No hepatic or renal insufficiency (creatinine above 2 mg / dL)
No preoperative anemia
No history of preoperative cardiopulmonary resuscitation
Parents' consent to participate in the research project
Exclusion criteria:
Hemodynamic instability
Emergency heart surgery
Lower the temperature during operation to below the desired temperature
Age
From 1 day old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of individuals to study groups was done in a randomized block method using 4 blocks. This work was done with the relevant software by the professor of statistics. In each block, there were 2 people belonging to group A and two people belonging to group B, whose order was random and the blocks were selected using a table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients' parents are given explanations about the study and the two groups to be studied, and then they are given consent to enter the study, but they are not told which group they are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Heart Hospital, Tehran
Street address
Valiasr St., the intersection of Niayesh Shahid Rajaei Heart Hospital
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
IR.RHC.REC.1398.082
Health conditions studied
1
Description of health condition studied
Congenital Acyanotic heart disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cerebral oxygenation
Timepoint
1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB.
Method of measurement
Based on the amount of INVOS
2
Description
Blood lactate
Timepoint
1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB.
Method of measurement
Laboratory kits
3
Description
Incidence of neurological complications
Timepoint
From postoperative time to discharge
Method of measurement
Based on patient records
4
Description
Average intubation time
Timepoint
From the time of surgery to Extubation
Method of measurement
Based on patient records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the mild hypothermia group (32 ° C) are treated as follows. The nasopharyngeal temperature will be maintained above 35 degrees for the time before the onset of cardiopulmonary bypass. For each child, 5 measurements are performed at different intervals: 1- at the time after induction of anesthesia (baseline value), 2- at the time of cooling up to 34 degrees Celsius, 3- at the time of the lowest level of cooling (first group 32 Degrees Celsius), 4- at reheating time (above 34 degrees Celsius), 5- after CPB completion.
Category
Other
2
Description
Intervention group: Patients in moderate hypothermia (28 ° C) are treated as follows. The nasopharyngeal temperature will be maintained above 35 degrees for the time before the onset of cardiopulmonary bypass. For each child, 5 measurements are performed at different intervals: 1- at the time after induction of anesthesia (baseline value), 2- at the time of cooling up to 34 degrees Celsius, 3- at the time of the lowest level of cooling (28 degrees Celsius), 4- at reheating time (above 34 degrees Celsius), 5- after CPB completion.