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IRCT20200228046634N1 IRCT 2021-05-15 Gonabad University of Medical Sciences The effect of salbutamol on pulmonary volumes and capacities Comparison the effect of salbutamol via nebulizer, spray with and without spacer on pulmonary function in Chronic Obstructive Pulmonary Disease (COPD) 2020-05-21 anticipated 66 Complete https://irct.ir/trial/47117 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: The study has a time series design, Randomization description: The research units will be selected as available in terms of study entry criteria and will be randomly assigned to the three groups of sprays, spacer and nebulizer using triple permutation blocks. In this method, if we consider the spray group A, the spacer group B, and the nebulizer group C, the six possible states in the triple blocks will be ABC-BAC-BCA-ACB-CAB-CBA, Each of these blocks will be assigned a number(We determine the number assigned to each block and it starts from 1). These numbers will be poured into a container and one of these numbers will be removed randomly by drawing lots at the beginning of sampling.Based on the selected number and the corresponding block, patients will be included in the study.After the arrival of the first three patients according to the designated block, a number was randomly removed from the container and sampling will continue. N/A Chronic Obstructive Pulmonary Disease (COPD). Intervention 1: The intervention group: receiving 200 micro grams of Salbutamol Equivalent to 2 puffs via Salbutamol spray under the Ventalex brand two minutes apart at a time. Intervention 2: The intervention group: receiving 200 micro grams of Salbutamol Equivalent to 2 puffs through Salbutamol spray under the Ventalex brand through spacer manufactured by Spadana Medical Technology Company two minutes apart at a time. Intervention 3: Intervention group: receiving 2.5 mg of Salbutamol solution of the Astalin brand through nebulizer type of ultrasound made by Rastak Medical Technology Company in one turn . Yes - There is a plan to make this available What will be shared: Potential data will be shared after unidentifiable individuals. When: Get started 8 months after the publication of results To whom: The researcher on academic institutions Conditions: The information should not be changed. Where to obtain: E-mail Maryam Derogar: dm.derogar72@gmail.com How to obtain: The E-mail to the given address and provide sufficient and acceptable information. Information will be given if data is acceptable. Comments:
public Maryam Derogar
No 4, Boostan 1Ave, Baharesttan Blvd, Farmandari Town
Gaen Iran (Islamic Republic of) 9861411957 +98 56 3249 6362 dm.derogar72@gmail.com Gonabad University of Medical Sciences scientific Dr. Kokab Basiri Moghaddam
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 5027 K.basiri@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) Satisfaction to participate in research Abnormal spirometry test including 0.7≥ FEV1/FVC ratio Age of 40-75 years old Physical ability to perform spirometry maneuvers Lack of pregnancy With body mass index between 18.5 - 25 Stages 1-4 of the disease based on GOLD criteria No specific intervention related to COPD or other possible diseases other than routine treatments Having awareness, the power of speech and communication Having a stable physiological state to answer questions No spirometry contraindications (uncontrolled blood pressure, infectious respiratory infection, active hemoptysis, recent eye or ear surgery, rupture of the tympanic membrane, recent history of CVA or pulmonary embolism, history of myocardial infarction or unstable angina in the last 6 weeks) 40 years 75 years Both Severely ill patients with COPD exacerbation with loss of consciousness or need for intubation Patients with comorbidity disorders such as heart failure, kidney, liver and diabetes Asthma, pneumonia and severe respiratory failure with cyanosis and confusion J44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs The intervention group: receiving 200 micro grams of Salbutamol Equivalent to 2 puffs via Salbutamol spray under the Ventalex brand two minutes apart at a time. The intervention group: receiving 200 micro grams of Salbutamol Equivalent to 2 puffs through Salbutamol spray under the Ventalex brand through spacer manufactured by Spadana Medical Technology Company two minutes apart at a time.. Intervention group: receiving 2.5 mg of Salbutamol solution of the Astalin brand through nebulizer type of ultrasound made by Rastak Medical Technology Company in one turn . The pulmonary volumes and capacities. Timepoint: The Measurement of pulmonary volumes and capacities at the beginning of the study and 15, 30, 60 and 90 minutes after the beginning of the intervention. Method of measurement: Perform the spirometry test in two consecutive days. The respiratory indicators. Timepoint: At the beginning of the study and 15, 30, 60 and 90 minutes after the beginning of the intervention. Method of measurement: The Respiratory Rate by counting the number of chest ups and downs and the percentage of oxygen saturation of the blood using the pulseoximetry device. Gonabad University of Medical Sciences Approved 2020-01-27 Ethics committee of Gonabad University of Medical Science Gonabad University of Medical Sciences, Next to the Asian Road, Gonabadوووو Gonabad Razavi Khorasan Iran (Islamic Republic of)