Comparing the duration of CO۲ blowing into the surgical field during cardiac bypass on arterial carbon dioxide pressure in patients undergoing minimally invasive mitral valve repair
Comparing the duration of CO۲ blowing into the surgical field during cardiac bypass on arterial carbon dioxide pressure in patients undergoing minimally invasive mitral valve repair
Design
Clinical trial with control group, with parallel groups, randomized on 50 patients. Computer generated permutation blocks (www.sealedenvelope.com) will be used for randomization.
Settings and conduct
Patients who are candidates for minimally invasive mitral valve repair who visit Dena Hospital in Shiraz during the study will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using the random block method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between 20 and 55 years old, Patients who candidate for minimally invasive mitral valve repair and Patients with normal pulmonary status.
Exclusion criteria: Positive history of liver and kidney failure, Positive history of Carotid artery stenosis, Positive history of brain diseases, Use of psychiatric medication and Alcoholic patients
Intervention groups
Control group (first group): In this study, all anesthesia conditions and settings of the pump device and prime oxygenator protocol are the same for all patients. Inminimally invasive mitral valve repair, surgeons inject carbon dioxide gas throughout the procedure at a speed of 6 liters per minute, which increases the blood co2 level of patients during the bypass period.
Intervention group (second group): In the patients of the second group, carbon dioxide injection is done only when rewarming the patient. With this timing, we try to reduce the related complications during cardiopulmonary bypass.
Main outcome variables
Arterial carbon dioxide pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230704058667N1
Registration date:2023-08-23, 1402/06/01
Registration timing:prospective
Last update:2023-08-23, 1402/06/01
Update count:0
Registration date
2023-08-23, 1402/06/01
Registrant information
Name
Amirghofran Ahmad Ali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
ghofran@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2024-07-01, 1403/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the duration of CO۲ blowing into the surgical field during cardiac bypass on arterial carbon dioxide pressure in patients undergoing minimally invasive mitral valve repair
Public title
Comparing the duration of CO۲ blowing into the surgical field during cardiac bypass on arterial carbon dioxide pressure in patients undergoing minimally invasive mitral valve repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients between 20 and 55 years old
Patients who candidate for minimally invasive mitral valve repair
Patients with normal pulmonary status
Exclusion criteria:
Positive history of liver and kidney failure
Positive history of Carotid artery stenosis
Positive history of brain diseases
Use of psychiatric medication
Alcoholic patients
Age
From 20 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 4 and 6 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 10 blocks will be selected randomly and patients will be allocated randomly and equally into two groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com.
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 Shiraz Medical School.
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.SUMS.MED.REC.1402.125
Health conditions studied
1
Description of health condition studied
Mitral regurgitation
ICD-10 code
I34.0
ICD-10 code description
Nonrheumatic mitral (valve) insufficiency
Primary outcomes
1
Description
Arterial carbon dioxide pressure
Timepoint
10, 30, 60, 90 minutes after induction of anesthesia and day 1, 2, 3 of hospitalization in ICU
Method of measurement
Arterial blood pressure was measured using an arterial blood sample and a blood gas analyzer.
2
Description
Postoperative Delirium
Timepoint
first and 2nd postoperative day
Method of measurement
Delirium Screening Questionnaire (Nu-DESC)
Secondary outcomes
empty
Intervention groups
1
Description
Control group (first group): In this study, all anesthesia conditions and settings of the pump device and prime oxygenator protocol are the same for all patients. Also, the cardioplegia solution used in all patients is the same. Inminimally invasive mitral valve repair (Minithoracotomy), surgeons inject carbon dioxide gas throughout the procedure at a speed of 6 liters per minute, which increases the blood co2 level of patients during the bypass period.
Category
Treatment - Surgery
2
Description
Intervention group (second group): our purpose in this study is to prevent the increase of CO2 during cardiopulmonary bypass and also to reduce air embolism by changing the time of carbon dioxide gas injection in the chest cavity. In the patients of the second group, carbon dioxide injection is done only when rewarming the patient. With this timing, we try to reduce the related complications during cardiopulmonary bypass.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dena Hospital
Full name of responsible person
Mozhdeh Eskandari
Street address
Dena Hospital,Blvd-E-Sattar Khan,Zargari Blvd.
City
Shiraz
Province
Fars
Postal code
7186764951
Phone
+98 71 3649 0411
Email
info@denahospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hashem Hashempour
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
hashempur@gmail.com
Web page address
https://rde.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?