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IRCT20211026052875N1 IRCT 2021-11-21 Rajaie Cardiovascular, Medical and Research Center The effect of mechanical ventilation during cardiopulmonary bypass surgery in adult cardiac valve surgery on inflammatory responses and pulmonary function The effect of mechanical ventilation during cardiopulmonary bypass surgery in adult cardiac valve surgery on inflammatory responses and pulmonary function 2021-11-22 anticipated 60 Complete https://irct.ir/trial/59934 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. N/A Diseases of the respiratory system. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period 6 months after printing the results To whom: It will be available to researchers working in academic and scientific institutions Conditions: To be aware of the study results and, if desired, use the results in other centers Where to obtain: They can refer to the person in charge of scientific responsibility How to obtain: The application will be emailed to the applicant within two weeks Comments:
public Fatemeh shima Hadipourzadeh
Ayattollah Hashemi Highway, cross valiasr Ave. Shahid Rajai Hospital
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 3740 shimahadipoorzadeh@gmail.com Iran University of Medical Sciences scientific Fatemeh shima Hadipourzadeh
Ayattollah Hashemi Highway, cross valiasr Ave. Shahid Rajai Hospital
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 3740 shimahadipoorzadeh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of)  All adult patients with age >35y undergoing elective cardiac valve surgery 35 years no limit Both 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 J96.0 Acute respiratory failure Prevention Prevention 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. 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. Inflammatory cytokines (IL-6, IL-8, IL-10,INT gamma,TNF alph). Timepoint: 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. Respiratory test. Timepoint: The day before surgery, the seventh day after surgery. Method of measurement: PFT and 6min Walking test before and after surgery. 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. Rajaie Cardiovascular, Medical and Research Center Approved 2021-03-06 Ethics committee of Shahid Rajaei Cardiovascular Research Center. Ayattollah Hashemi Highway, cross valiasr Ave. Shahid Rajai Hospital Tehran Tehran Iran (Islamic Republic of)