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IRCT20101220005426N12 IRCT 2022-10-29 Kerman University of Medical Sciences A comparison of two stem cells utilization methods; intravenous and intra alveolar injection by bronchoscope on outcome of severe lung contusion A comparison of two stem cells utilization methods; intravenous and intra alveolar injection by bronchoscopy on outcome of severe lung contusion in patients admitted to intensive care unit (ICU) 2022-11-06 anticipated 30 Complete https://irct.ir/trial/65529 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize people to three groups, the block randomization method is used in such a way that blocks of size 6 are used. R statistical software is used for random block allocation, Blinding description: It is a one-way blind method in which stem cells are injected by an ICU specialist. Examination of pneumonia (CPIS criteria, clinical history, clinical examination and chest x-ray) will be done by an anesthesiologist, and the arterial oxygen pressure will be checked by the senior ICU nurse who does not know the type of cell injection to the patients. Also, laboratory tests will be done by a technician who's not aware of the interventions will be made. 2 lung contusion. Intervention 1: Intervention group 1: The first group will receive 60 million dental pulp stem cells intravenously in addition to common supportive treatments. Intervention 2: Intervention group 2: The second group, in addition to common supportive treatments, 60 million dental pulp stem cells are pushed by a bronchoscope inside the lung alveoli in the contusion area (based on CT scan findings). Intervention 3: Control group: They will only be treated by usual treatments. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mehdi Ahmadinejad
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 0223 5011 mehdia50@gmail.com Kerman University of Medical Sciences scientific Mehdi Ahmadinejad
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 0223 5011 mehdia50@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) The pressure of arterial oxygen to inspiratory oxygen should be less than 180(PaO2/FIO2<180) Bilateral infiltration with pulmonary edema in anterior lung radiography Pulmonary contusion greater than 40% in chest CT scan The need to transfer to the intensive care unit due to respiratory failure Criteria 1-4 must all be present within a 24-hour period at the time of study entry 18 years 65 years Both More than 96 hours have passed since the patient's ARDS trauma Pregnant or lactating woman Presence of any active malignancy (other than nonmelanoma skin cancer) that requires treatment within 2 years Any irreversible disease such as malignancies and a condition with a 50% chance of death within the next six months Moderate to severe liver disorder based on Child-Puff criteria<12 chronic obstructive pulmonary disease(COPD) The patient has undergone a lung transplant The patient's lack of consent, or if the patient is unable to answer, the patient's guardian's lack of consent A patient who is not expected to be alive in the next 24 hours according to the Apache criteria Class III or IV pulmonary hypertension Pulmonary embolism or deep vein thrombosis in the past three months Brain trauma Transfusion of large volume of blood (injection of more than 10 units of blood in the last 24 hours) The presence of heart failure, kidney and diabetes Patients in a state of shock and previous concurrent contusion S27.32 Contusion of lung Treatment - Other Treatment - Other Treatment - Drugs Intervention group 1: The first group will receive 60 million dental pulp stem cells intravenously in addition to common supportive treatments Intervention group 2: The second group, in addition to common supportive treatments, 60 million dental pulp stem cells are pushed by a bronchoscope inside the lung alveoli in the contusion area (based on CT scan findings). Control group: They will only be treated by usual treatments Arterial oxygen pressure to inspiratory oxygen pressure ratio. Timepoint: The ratio of arterial oxygen pressure to inspiratory oxygen pressure at the beginning of the study (before the start of the intervention) and 1, 4 and 10 days after cell injection in intervention and control groups. Method of measurement: ABG. Average duration (days) of ventilation. Timepoint: After the intervention, daily until the end of hospitalization. Method of measurement: check list. Death. Timepoint: death between 28 and 60 days after the start of the study. Method of measurement: Check list. Average period of stay in ICU. Timepoint: The average period of stay in the ICU between 28 and 60 days after the start of the study in the intervention and control groups. Method of measurement: check list. Need for intubation. Timepoint: Need for intubation during the study. Method of measurement: Check list. Forced expiratory volume in the first one second to the forced vital capacity(FEV1/FVC). Timepoint: forced expiratory volume in the first one second to the forced vital capacity(FEV1/FVC) at the 1, 3 and 6 months after the start of study in intervention and control groups. Method of measurement: spirometry. Forced vital capacity. Timepoint: Forced vital capacity at the 1, 3 and 6 months after the start of study in intervention and control groups. Method of measurement: spirometry. Kerman University of Medical Sciences Approved 2022-06-25 Ethic committee, Kerman University of Medical Sciences Vice chancellor for research, Kerman University of Medical Sciences, Jahad street Kerman Kerman Iran (Islamic Republic of)