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IRCT20161106030735N2 IRCT 2020-12-02 Tehran University of Medical Sciences The effect of ASV ventilation mode on respiratory failure Evaluation of the effect of using Adaptive support ventilation (ASV) in comparison with Synchronized intermittent mandatory ventilation (SIMV) method on lung mechanics in Respiratory Failure Patients Hospitalized in Intensive Care Unit 2020-11-20 anticipated 64 Complete https://irct.ir/trial/52094 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The two groups are divided based on a list of random numbers generated by computer software.Based on the number list with numbers 1 for ASV and 2 for SIMV, patients are randomly divided and entered the study, respectively. N/A Acute hypoxemic respiratory failure. Intervention 1: In the ASV or intervention group,Minute Volume:100% and pressure set on 30 CmH2O to reach O2Saturation: 88-92% and PEEP = 5 and flow trigger 1-3 l / min.As the patient's condition improves, the minute volume is reduced to 70% and then to 50% and then 30% to reach a minimum pressure of 5 cmH2O. Intervention 2: Control group:In SIMV group, when the patient reaches PEEP <8 cmH2O and FiO2 <0.4 and 8 PS <cmH2O, they go to spontaneous ventilation mode with the same ventilator towards FiO2: 40%, PEEP = 3cmH2O, PS = 3 cmH2O and trigger: 2. Yes - There is a plan to make this available What will be shared: Individual data is recorded and archived in the datasheet. All data can be shared after unidentifiable study subjects. When: Access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: No other analysis is allowed. Where to obtain: To receive the data, they can send a request to the following email address. enaseh@razi.tums.ac.ir How to obtain: To receive the data, they can send a request to the following email address. enaseh@razi.tums.ac.ir. Information will be made available to eligible individuals within 24 hours. Comments:
public Elham Naseh
Tehran University of Medical Science, Poorsin street, Keshavarz avenue
Tehran Iran (Islamic Republic of) 1136746911 +98 21 84901 enaseh@razi.tums.ac.ir Tehran University of Medical Sciences scientific Atabak Najafi
Sina Hospital, Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 enaseh@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Intubated patients with acute respiratory failure type I (hypoxemic) Endotracheal intubation and mechanical ventilation less than 48 hours Respiratory failure based on PaO2/FiO2=150-250 (P / F Ratio = 150-250) 16 years 85 years Both Patients with acute respiratory failure and PaO2/FiO2( P / F Ratio) less than 150 Neuromuscular and diaphragmatic disorders Chest deformity Suspected Intracranial Hypertension Chronic obstructive pulmonary disease and severe asthma Chronic heart failure Chronic renal failure Refractory shock Diagnosed Barotrauma and Lung Contusion Age under 16 and over 85 years Pregnancy Abdominal compartment syndrome J96.01 Acute respiratory failure with hypoxia Treatment - Devices Treatment - Devices In the ASV or intervention group,Minute Volume:100% and pressure set on 30 CmH2O to reach O2Saturation: 88-92% and PEEP = 5 and flow trigger 1-3 l / min.As the patient's condition improves, the minute volume is reduced to 70% and then to 50% and then 30% to reach a minimum pressure of 5 cmH2O Control group:In SIMV group, when the patient reaches PEEP <8 cmH2O and FiO2 <0.4 and 8 PS <cmH2O, they go to spontaneous ventilation mode with the same ventilator towards FiO2: 40%, PEEP = 3cmH2O, PS = 3 cmH2O and trigger: 2 Lung compliance. Timepoint: Measurement of lung compliance on days 1, 2, 3 and 7 after ASV or SIMV setting. Method of measurement: compliance measurment is based on ventilator information. Lung resistance. Timepoint: Measurement of lung resistance on days 1, 2, 3 and 7 after ASV or SIMV setting. Method of measurement: resistance measurment is based on ventilator information. Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Scoring System. Timepoint: At the time of admission. Method of measurement: According to the case report. Oxygenation based on the ratio of arterial oxygen pressure to the Fio2. Timepoint: Days 1, 2, 3 and 7 after the start of ventilation mode. Method of measurement: Based on sample information of ABG blood gas analysis. Arterial blood carbon dioxide pressure PaCO2. Timepoint: Days 1, 2, 3 and 7 after the start of ventilation mode. Method of measurement: Based on sample information of ABG blood gas analysis. Fentanyl intake. Timepoint: Days 1, 2, 3 and 7 after the start of ventilation mode. Method of measurement: Based on patient record (micrograms). Number of ventilator free days at day 28. Timepoint: Twenty-eighth day after intervention. Method of measurement: Based on patient record. Intensive care unit length of stay. Timepoint: At the time of discharge from the intensive care unit. Method of measurement: Based on patient record. Richmond Agitation and Sedation Scale (RASS score). Timepoint: Days 1, 2, 3 and 7 after the start of ventilation mode. Method of measurement: Based on patient record. Tehran University of Medical Sciences Approved 2019-12-10 Ethic cmmittee,faculty of medicine of Tehran University of mdical science Tehran universiy of medical science, faculty of medicine, Poorsina street,Keshavarz avenue Tehran Tehran Iran (Islamic Republic of)