The effect of mechanical ventilation during cardiopulmonary bypass surgery in adult cardiac valve surgery on inflammatory responses and pulmonary function
Evaluation of the effect of mechanical ventilation during cardiopulmonary bypass surgery in adult cardiac valve surgery on inflammatory responses and pulmonary function
Design
This study is a clinical trial study that is performed after the approval of the ethics committee and after obtaining informed written consent from all patients in Shahid Rajaei Heart Center. This study is performed over a period of 18 months and according to the statistical calculation, 30 patients are examined in each group.
Settings and conduct
This study will be performed in the operating room of Shahid Rajaei Cardiovascular Research Center. All patients underwent PFT and 6 minute walking test before surgery. In all patients in both groups, inflammatory cytokines before and after CPB will be measured also after extubation in ICU. And are compared in both groups, also PFT and 6min test are performed on the seventh day after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All adult patients undergoing elective cardiac valve surgery
Exclusion criteria:
o Emergency surgery
o Congenital heart surgery
o Patients undergoing third and more valve resections
o Patients with coagulation disease
o Patients undergoing dialysis
o Patients with pulmonary problems
o fractional ejection less than 35%,
o Patients with open sternum
o if the surgeon's vision decreases during cardiac surgery due to continued mechanical ventilation, the ventilation will stop
o patients who remain intubated for more than 12 hours
o patients who are transferred to the operating room for any reason
Intervention groups
In this study, mechanical ventilation with TV = 3cc / Kg, RR = 6, PEEP = 5 and FI02 = 1 continues in the intervention group during cardiopulmonary bypass.
Main outcome variables
IL-6, IL-8, IL-10,INT gamma, TNF alph; respiratory test; duration of stay in the intensive care unit and hospital (ویرایششد
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211026052875N1
Registration date:2021-11-21, 1400/08/30
Registration timing:prospective
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
Shima Hadipourzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 3740
Email address
shimahadipourzadeh@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mechanical ventilation during cardiopulmonary bypass surgery in adult cardiac valve surgery on inflammatory responses and pulmonary function
Public title
The effect of mechanical ventilation during cardiopulmonary bypass surgery in adult cardiac valve surgery on inflammatory responses and pulmonary function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients with age >35y undergoing elective cardiac valve surgery
Exclusion criteria:
patients undergoing emergency surgery
Patients undergoing congenital heart surgery
Patients undergoing third and more valve resections
Patients with coagulation disease
Patients undergoing dialysis
Patients with pulmonary problems such as COPD who are in stage one and four due to FEV1 ( stage1:mild FEV1≥80%، stage2:moderate FEV1 50-79%، stage3:severe FEV130-49% ، stage 4: very severe FEV1 ≤30% )
Patients with fractional ejection less than 35%,
Patients who transfer to the ICU with open sternum
In this study, if the surgeon's vision decreases during cardiac surgery due to continued mechanical ventilation, the ventilation will stop and the patient will be excluded from the study
Patients who remain intubated for more than 12 hours after transfer to the ICU due to hemodynamic instability
patients who are transferred to the operating room for any reason
Age
From 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all blocks is the same and we will have 2 groups of 6 blocks in this two-group experiment, including 3 participants in the intervention group and 3 participants in the control group. Random allocation software is also used for randomization tools. In addition to simple randomization, these random sequence generation software is able to generate random sequences by blocking method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence in (Sequentially numbered, sealed, opaque envelopes) this method, each of the random sequences created is recorded on a card and the cards in the envelopes to They are placed in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The anesthesiologist and the laboratory are aware of blindness in the study group, but, patient is unaware of the study group, and the study is one-sidedly blind. The patients are explained that they are in one of the two study groups and the patients are anesthetized during the operation and remains unaware of 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 Cardiovascular Research Center.
After induction of anesthesia and placement of the central vein; after separation from cardiopulmonary bypass; after extubation
Method of measurement
Inflammatory cytokines using venous blood samples in operation room and ICU
2
Description
Respiratory test
Timepoint
The day before surgery, the seventh day after surgery
Method of measurement
PFT and 6min Walking test before and after surgery
Secondary outcomes
1
Description
length of stay in hospital and intensive care unit
Timepoint
After discharge from hospital
Method of measurement
length of stay in hospital and intensive care unit according to patient records
Intervention groups
1
Description
Intervention group: In this study, mechanical ventilation with TV = 3cc / Kg, RR = 6, PEEP = 5 and FI02 = 1 continues in the intervention group during cardiopulmonary bypass and blood samples are sent for inflammatory cytokines beforeand after cardiopulmonary bypass.
Category
Prevention
2
Description
Control group: Control group: In this group, mechanical ventilation is stopped during cardiopulmonary bypass and blood samples are sent for inflammatory cytokines beforeand after cardiopulmonary bypass.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular, Medical and Research Center