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IRCT20200509047376N1 IRCT 2020-11-24 Tehran University of Medical Sciences The effect of APRV ventilation mode on respiratory failure Evaluation of the effect of using Airway Pressure Release Ventilation (APRV) in comparison with Pressure Support Ventilation (PSV) method in lung mechanics in patients with Acute Respiratory Failure (ARF) admitted to intensive care unit 2020-11-12 anticipated 52 Complete https://irct.ir/trial/52202 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The two groups are divided based on random numbers generated by computer software. N/A Acute hypoxemic respiratory failure. Intervention 1: Intervention group: APRV: Patients change from previous volume ventilation mode to APRV mode. P-high is adjusted to create VT = 6ml / kg and does not exceed 30cmH2O. From 60%, produce PaO2 above 60. The T-low is set to 1 to 1.5 times the expiratory time constant (TE). T-high is adjusted so that the release frequency is set to 10-14 / min and PaCO2 is maintained in the normal range. Intervention 2: Control group: PSV: Patients on pressure mode with PIP and PS with the aim of creating a tidal volume equal to 6 ml per kg of ideal weight. PEEP to the extent that with FIO2 less than 60%, PaO2 above 60 Slowly adjusted. 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: En To receive the data, they can send a request to the following email address. elhamnaseh63@gmail.com How to obtain: En To receive the data, they can send a request to the following email address. elhamnaseh63@gmail.com. Information will be made available to eligible individuals within 24 hours. Comments:
public Elham Naseh
Tehran University of Medical Science, Poorsin street, Keshavarz ave.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 84901 elhamnaseh63@gmail.com Tehran University of Medical Sciences scientific Atabak Najafi
Sina Hospital, Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 elhamnaseh63@gmail.com 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 P / F Ratio = 150-250 16 years 85 years Both Patients with acute respiratory failure and P / F Ratio less than 150 Neuromuscular and diaphragmatic disorders Chest deformity Suspected Intracranial Hypertension COPD and severe asthma CHF CKD , ESRD Refractory shock Diagnosed Barotrauma and Lung Contusion Age under 16 and over 85 years Pregnancy Abdominal compartment syndrome J96.0 Acute respiratory failure Treatment - Devices Treatment - Devices Intervention group: APRV: Patients change from previous volume ventilation mode to APRV mode. P-high is adjusted to create VT = 6ml / kg and does not exceed 30cmH2O. From 60%, produce PaO2 above 60. The T-low is set to 1 to 1.5 times the expiratory time constant (TE). T-high is adjusted so that the release frequency is set to 10-14 / min and PaCO2 is maintained in the normal range. Control group: PSV: Patients on pressure mode with PIP and PS with the aim of creating a tidal volume equal to 6 ml per kg of ideal weight. PEEP to the extent that with FIO2 less than 60%, PaO2 above 60 Slowly adjusted. Lung compliance. Lung resistance. Timepoint: Measurement of lung compliance and resistance on days 1, 2, 3 and 7 after long-term onset of APRV and PSV. Method of measurement: compliance and 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: روزهای 1و2و3و7 بعد از شروع مد تهویه ای. 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. The amount of shunt: (1-SaO2)/(1-SvO2). Timepoint: Days 1, 2, 3 and 7 after the start of ventilation mode. Method of measurement: Based on ABG information. Tehran University of Medical Sciences Approved 2019-02-23 Ethics committee of Tehran University of Medical Sciences Sina Hospital, Imam Khomeini Ave.,Imam Khomeini Square Tehran Tehran Iran (Islamic Republic of)