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IRCT201507307494N14 IRCT 2015-09-22 Vice Chancellor for research Mazandaran University of Medical Sciences. Effect of Different Levels Positive End-Expiratory Pressure on the Incidence of Atelectasis After Heart Surgery Effect of Different Levels Positive End-Expiratory Pressure on the Incidence of Atelectasis After Heart Surgery 2015-09-23 anticipated 180 Complete https://irct.ir/trial/7965 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Patients are randomly assigned to the groups using random numbers table. The study is considered as Double blind, as except the researcher, all patients and radiologists are not aware of the randomized allocation of samples. 2 Atelectasis. Intervention 1: Patient in the intermediate level of intervention will receive an average 8 cmH2O positive end-expiratory pressure (PEEP) for 4 hours, 30 minutes after entering the intensive care unit, (provided that the hemodynamic status is not disrupted). They will receive 5 cmH2O PEEP until the endotracheal tube removal. Intervention 2: Patient in the high level of intervention will receive an average 10 cmH2O positive end-expiratory pressure (PEEP) for 4 hours, 30 minutes after entering the intensive care unit, (provided that the hemodynamic status is not disrupted). They will receive 5 cmH2O PEEP until the endotracheal tube removal. Intervention 3: Patients in the control group receive 5 cmH2O positive end-expiratory pressure after surgery, 30 minutes after entering the intensive care unit until the removal of the endotracheal tube.
public Dr Masumeh Bagheri Nesami
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7551 anna3043@gmail.com Mazandaran University of Medical Sciences scientific Dr Masumeh Bagheri Nesami
Mazandaran University of Medical Sciences, three way Joibar, highway Basij, Imam square, Sari, Mazand
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7551 anna3043@gmai.com; mbagheri@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria including: Patients candidate for non emergency open heart surgery (coronary artery bypass and heart valve surgery by sternotomy and cardiopulmonary bypass); Aged from 18 until 65 years; No ejection fraction less than 30% in the angiography form, preoperative; No history of chronic airway obstruction disease and lung trauma; No history of open heart surgery or lung surgery; No history of rib fractures and chest tube insertion; No history of trauma in the head or nose, neurologic disease and frequent sinus infections; No history of chemotherapy and using immunosuppressants three months prior to the surgery; No serum creatinine greater than 3.5 mg/Dl; No body mass index greater than 40 kg/m2; Consciousness level at 15 before surgery; Exclusion criteria including: Arterial systolic pressure less than 90 mmHg despite of fluid intake; Arterial blood pH less than 7.30; Arterial carbon dioxide pressure greater than 50 mmHg; Arterial oxygen saturation less than 80% despite of supplemental oxygen intake; Hemoglobin concentration less than 7 gr/dL; Aortic cross clamp time longer than 150 minutes; Cardiopulmonary bypass time longer than 240 minutes; Using intra aortic balloon pump (IABP) intraoperative and postoperative; Intubation over 24 hours; Also, the patient will be excluded from the study when he/she retransfers to the operating room or when he/she needs ventilator therapy protocols apart from of research protocols. 18 years 65 years Both J98.1 Pulmonary collapse Prevention Prevention Prevention Patient in the intermediate level of intervention will receive an average 8 cmH2O positive end-expiratory pressure (PEEP) for 4 hours, 30 minutes after entering the intensive care unit, (provided that the hemodynamic status is not disrupted). They will receive 5 cmH2O PEEP until the endotracheal tube removal. Patient in the high level of intervention will receive an average 10 cmH2O positive end-expiratory pressure (PEEP) for 4 hours, 30 minutes after entering the intensive care unit, (provided that the hemodynamic status is not disrupted). They will receive 5 cmH2O PEEP until the endotracheal tube removal. Patients in the control group receive 5 cmH2O positive end-expiratory pressure after surgery, 30 minutes after entering the intensive care unit until the removal of the endotracheal tube. Atelectasis. Timepoint: Two hours after extubation, the third day after surgery (72 hours of operation). Method of measurement: Chest x-rays. Respiratory variable of arterial blood gas (arterial oxygen tension, arterial carbon dioxide tension, arterial oxygen saturation, arterial bicarbonate and arterial blood PH). Timepoint: Before the intervention, one and four hours after the starting of the intervention, before extubation. Method of measurement: ABG test. Arterial systolic pressure, diastolic blood pressure and mean arterial pressure. Timepoint: Before the intervention, one and four hours after the starting of the intervention, before extubation. Method of measurement: Advanced vital signs monitoring devices. Heart rate. Timepoint: Before the intervention, one and four hours after the starting of the intervention, before extubation. Method of measurement: Advanced vital signs monitoring devices. Respiratory rate. Timepoint: Before the intervention, one and four hours after the starting of the intervention, before extubation. Method of measurement: Counting the number of breaths per minute. Tempreture. Timepoint: Before the intervention, one and four hours after the starting of the intervention, before extubation. Method of measurement: Advanced vital signs monitoring devices thermometer. Vice Chancellor for research Mazandaran University of Medical Sciences. Approved 2015-07-23 Ethics Committee of Mazandaran University of Medical Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran. sari Iran (Islamic Republic of)