Objective: Comparing the effect procedural type on Arterial-End tidal CO2 pressure difference (DPCO2) in pediatric cardiac surgery:corrective vs. palliative
Design: Non randomized clinical trial
Setting and conduct: Two hundred pediatric patients up to 12 years old, candidate for elective corrective or palliative cardiac surgery enrolled to study. Anesthesia will be induced using ketamine, midazolam and cisatracurium. Using direct arterial blood gas and simultaneous capnography, DPCO2 will be measured by a coworker who is blinded to the operation type, after anesthesia induction,at immediately post procedure, ends of surgery,ICU admit and before extubation. At the end of study,patients will be classified in two corrective or palliative procedural groups and DPCO2 changes will be compared between two corrective or palliative groups at various periods.
Inclusion criteria: Patients up to 12 Years old who are candidate for elective cardiac surgery
Exclusion criteria: Urgent surgery; surgery; age above 12 years old
Intervention: corrective or palliative cardiac surgery
Outcome measures: Arterial-End tidal CO2 pressure difference
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606011127N5
Registration date:2016-06-07, 1395/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-07, 1395/03/18
Registrant information
Name
Eissa Bilehjani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6124
Email address
bilehjanii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-02, 1393/06/11
Expected recruitment end date
2015-09-02, 1394/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of corrective or palliative procedures on Arterial-End tidal CO2 pressure difference in pediatric cardiac surgery
Public title
Comparing the effect of procedural type on Arterial-End tidal CO2 pressure difference in pediatric cardiac surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patients up to 12 Years old who are candidate for corrective or palliative elective cardiac surgery
Exclusion criteria: Urgent surgery; surgery; age above 12 years old
Age
From 1 day old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2012-03-14, 1390/12/24
Ethics committee reference number
14/7-3/90
Health conditions studied
1
Description of health condition studied
cogenital heart diseases
ICD-10 code
Q24.8
ICD-10 code description
Other specified congenital malformations of heart
Primary outcomes
1
Description
arterial and end tidal carbon dioxide pressure difference
Timepoint
after anesthesia induction, immediately post procedure, ends of surgery and before extubation
Method of measurement
Simultaneous arterial blood gas analysis and capnography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Total corrective cardiac surgery
Category
Treatment - Surgery
2
Description
control group: Palliative cardiac surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Heart Hospital
Full name of responsible person
Eissa Bilehjani
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tabriz 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
Medicine faculty, Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleiman Pour
Position
Vice Chancellor for research of Tabriz University of Medical Sciences