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IRCT20151003024317N12 IRCT 2020-11-10 Iran University of Medical Sciences Evaluation of the effect of nebulised Furosemide on acute dyspnea comparison of effects of nebulised Furosemide, oxygen and placebo in patients with acute dyspnea transmited to hospitals by EMS 2020-11-21 anticipated 300 Complete https://irct.ir/trial/44650 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to tree groups by using a random number table. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 12. In each block, 4 individuals will be in intervention group 1, 4 individuals will be in intervention group 2 and 4 will be in control group. A total of 25 blocks will be considered for the study, Blinding description: Clinical caregivers and patients will be unaware and blind to the type of treatment. Similar serums were used for concealment, without drug name label and only with code. Patients will be aware that they will be randomly assigned to one of three treatment groups, but will not know which treatment will be offered in that group. Patients will be placed in one of three groups using a random number table. The clinician also knows that patients will be treated in three different ways, but will not know which method will be used for each patient. The data collector, analyst, outcome assessor, and data safety and monitoring committee will collect and analyze the information based on groups 1, 2, and 3, and will not be aware of the type of treatment provided in the groups. They will be kept blind. 3 Acute dyspnea. Intervention 1: Intervention group 1: In addition to routine treatment, 40 mg of inhaled furosemide will be given as a nebulizer at the scene. Intervention 2: Intervention group 2: In addition to routine treatment, oxygen will be prescribed at the scene with a mechanical nebulizer. Intervention 3: Control group: In addition to routine treatment, 10 cc of normal saline will be prescribed as a placebo at the scene. 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 work and consulting with all the writers and executive agents, I will be decided.
public Babak Mahshidfar
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2190 mahshidfar.b@iums.ac.ir Iran University of Medical Sciences scientific Babak Mahshidfar
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2190 mahshidfar.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Acute dyspnea Patient transfer by pre-hospital emergency patients over 18 years old 18 years 75 years Both patients over 75 years old Patients require mechanical ventilation Loss of consciousness Accompanied by another disease that requires treatment in the first 10 minutes of treatment with digoxin, beta-blocker, beta-agonist and calcium blocker Need another inhalation treatment in the first 10 minutes Need non-invasive positive pressure ventilation R06.0 Dyspnea Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: In addition to routine treatment, 40 mg of inhaled furosemide will be given as a nebulizer at the scene. Intervention group 2: In addition to routine treatment, oxygen will be prescribed at the scene with a mechanical nebulizer. Control group: In addition to routine treatment, 10 cc of normal saline will be prescribed as a placebo at the scene. Acute dyspnea. Timepoint: Before intervention, thirty minutes after intervention. Method of measurement: Shortness of breath chart. Percentage of oxygen saturation. Timepoint: Before intervention, thirty minutes after intervention. Method of measurement: Percentage of oxygen saturation. Heart rate. Timepoint: Before intervention, thirty minutes after intervention. Method of measurement: Based on the information recorded in patient's record. Number of breaths. Timepoint: Before intervention, thirty minutes after intervention. Method of measurement: Based on the information recorded in patient's record. Iran University of Medical Sciences Approved 2020-10-07 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)