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IRCT20210830052333N1 IRCT 2021-10-13 Shahroud University of Medical Sciences Comparison of hospitalization time of patients with different treatments of deoulin nebulizer, deoulin nebulizer with inhalation spray and deoulin nebulizer and pulmicort simultaneously in patients with chronic obstructive pulmonary disease Comparison of hospitalization time with deoulin nebulizer, deoulin nebulizer with inhalation spray and deoulin nebulizer and pulmicort simultaneously in patients with chronic obstructive pulmonary disease in the disease exacerbation stage 2021-09-23 anticipated 174 Complete https://irct.ir/trial/58438 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated to two intervention groups and one control groups according to random allocation table that illustrated by a statistician. Randomization was done using permuted block randomization method (Block size was 4) using blocked random allocation syntax in SPSS software. For calculation sample size was 174 and number of blocks was 44. Allocation concealment was done using closed opaque envelope. 2-3 Chronic obstructive pulmonary disease. Intervention 1: Intervention group 1: For the first intervention group, in addition to routine treatments including oxygen therapy, deoulin nebulization (salbutamol + ipratropium bromide) in a 2.5 ml vial every 20 minutes once to three times with salbutamol and atrovent sprays 8 puffs and repeat both sprays up to three times every 20 minutes with the use of asmyar will be prescribed . Intervention 2: Intervention group 2: For the second intervention group, in addition to routine treatments including oxygen therapy, deoulin nebulization (salbutamol + ipratropium bromide) in a 2.5 ml vial every 20 minutes once to three times with a half-milligram Pulmicort vial every 20 minutes for three times will be prescribed . Intervention 3: Control group: For the control group, in addition to routine treatments including oxygen therapy, 2.5 ml deoulin nebulization will be prescribed in the first stage and repeated every 20 minutes up to three times. 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 After completing the research and summarizing the results, a decision will be made in consultation with the facilitators and colleagues.
public Parisa Soleymani
Imam Hossein Hospital, End Imam street, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 parisasoleimani1073@yahoo.com Shahroud University of Medical Sciences scientific Dr. Maryam Khodayar
Imam Hossein hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 khodayar@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 80 years; Patients with confirmed diagnosis of chronic obstructive pulmonary disease by spirometric and clinical findings; Chronic illness for at least the last six months; Do not take any antibiotics for at least the last month; Conscious consent to participate in research. 18 years 80 years Both Loss of consciousness; Severe restlessness; Severe respiratory distress with oxygen pressure less than 60 mm Hg and carbon dioxide pressure greater than 45 mm Hg in a venous gas sample; Severe heart failure; Pulmonary embolism; Use of any opium in the past month; Existence of severe infectious diseases of the respiratory tract for at least one month; History of any surgery on the respiratory tract. J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: For the first intervention group, in addition to routine treatments including oxygen therapy, deoulin nebulization (salbutamol + ipratropium bromide) in a 2.5 ml vial every 20 minutes once to three times with salbutamol and atrovent sprays 8 puffs and repeat both sprays up to three times every 20 minutes with the use of asmyar will be prescribed . Intervention group 2: For the second intervention group, in addition to routine treatments including oxygen therapy, deoulin nebulization (salbutamol + ipratropium bromide) in a 2.5 ml vial every 20 minutes once to three times with a half-milligram Pulmicort vial every 20 minutes for three times will be prescribed . Control group: For the control group, in addition to routine treatments including oxygen therapy, 2.5 ml deoulin nebulization will be prescribed in the first stage and repeated every 20 minutes up to three times. The amount of hospitalization hours in the emergency department. Timepoint: Once an hour. Method of measurement: Count the hours of hospitalization. Measuring the extent of disease severity reduction. Timepoint: Once an hour. Method of measurement: By counting the number of breaths per minute. Maximum expiratory volume per the first second (FEV1). Timepoint: Once an hour. Method of measurement: Micromedical spirometer. Measurement of arterial blood oxygen saturation. Timepoint: Once an hour. Method of measurement: Arterial blood oxygen measurement test with ABG device. Measurement of venous blood carbon dioxide saturation. Timepoint: Once an hour. Method of measurement: Carbon dioxide test with ABG device. Vice chancellor for research; Shahroud University medical and Sciences Approved 2020-05-12 Ethics committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences; 7 Tir squer, Shahroud Shahroud Semnan Iran (Islamic Republic of)