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IRCT20180129038549N15 IRCT 2021-12-20 Esfahan University of Medical Sciences Effect of high-pressure nasal cannula and conventional oxygen treatment in Covid-19 Comparison of the effect of high-pressure nasal cannula and conventional oxygen treatment in Covid-19 patients referred to the emergency department 2021-12-22 anticipated 66 Complete https://irct.ir/trial/60714 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the arrival of the patients to the emergency department, they are divided into 2 groups by a computer-generated random number table with 4 blocks. The selected subjects will be divided into each study group in a randomized block method using 9 rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). Case group (A) and control group (B). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined, Blinding description: Patients are first treated with nasal oxygen for at least 15 minutes and then if they do not improve and do not increase the oxygen saturation above 90% to continue treatment of patients are divided into two groups. In the study group, high-pressure nasal oxygen is used for patients, and in the control group, an oxygen mask with oxygen greater than or equal to 6 liters per minute is used. Patients must be treated for at least one hour before entering the study and then evaluated. Then all the information is collected by a researcher who is blinded to randomization. 3 Condition 1: Respiratory failure. Condition 2: Covid-19. Intervention 1: Intervention group: Covid-19 patients admitted to the emergency department are first treated with nasal oxygen for at least 15 minutes and then, if they do not improve and the oxygen level in the pulse oximetry does not exceed 90%, continue treatment with high-pressure nasal cannula up to a maximum of 60 liters per minute. Patients must be treated for at least one hour before entering the study and then evaluated. Intervention 2: Control group: Covid-19 patients admitted to the emergency department are initially treated with normal nasal oxygen for at least 15 minutes. If there is no improvement and no increase in oxygen level in the pulse oximetry above 90%, to continue treatment for patients, a non-rebreather oxygen mask with oxygen greater than or equal to 6 liters per minute for one hour is used and then patients are evaluated. Yes - There is a plan to make this available What will be shared: All of the data after coding When: Six months after publication To whom: Everyone Conditions: For seemingly studies data released to academic chairman's Where to obtain: Isfahan University of Medical Sciences How to obtain: Emailing to farhad_heidari@med.mui.ac.ir Comments:
public Farhad Heydari
No 7, Aria Building, Sohrevardi Ave.
Isfahan Iran (Islamic Republic of) 8177777645 +98 31 3776 9818 drfarhadheydari@gmail.com Esfahan University of Medical Sciences scientific Farhad Heydari
No 7, Aria Building, Sohrevardi Ave.
Isfahan Iran (Islamic Republic of) 8177777645 +98 31 3776 9818 drfarhadheydari@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Oxygen saturation less than 90% despite receiving nasal oxygen ≥ 3 L/min or respiratory rate more than 24 breaths per minute The diagnosis of Covid-19 is confirmed based on PCR or lung HRCT Alert patients 18 years no limit Both Unstable hemodynamics Obesity Hypoventilation Syndrome Respiratory failure due to pulmonary edema Patients who do not tolerate the use of high pressure oxygen Cases in which emergency intubation is required Pregnant women J96.0 B34.2 Acute respiratory failure Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Covid-19 patients admitted to the emergency department are first treated with nasal oxygen for at least 15 minutes and then, if they do not improve and the oxygen level in the pulse oximetry does not exceed 90%, continue treatment with high-pressure nasal cannula up to a maximum of 60 liters per minute. Patients must be treated for at least one hour before entering the study and then evaluated. Control group: Covid-19 patients admitted to the emergency department are initially treated with normal nasal oxygen for at least 15 minutes. If there is no improvement and no increase in oxygen level in the pulse oximetry above 90%, to continue treatment for patients, a non-rebreather oxygen mask with oxygen greater than or equal to 6 liters per minute for one hour is used and then patients are evaluated. Increased blood oxygen saturation. Timepoint: One hour after treatment. Method of measurement: Pulse oximetry. Vital signs include heart rate and respiratory rate and systolic and diastolic blood pressure. Timepoint: One hour after treatment. Method of measurement: Manometer( pressure gauge) and count. Intubation rate. Timepoint: Until discharge from the hospital. Method of measurement: Count. Intensive care unit admission rate. Timepoint: Until discharge from the hospital. Method of measurement: Count. Mortality rate. Timepoint: Until discharge from the hospital. Method of measurement: Count. Esfahan University of Medical Sciences Approved 2021-11-26 Ethics committee of Isfahan University of Medical Science Isfahan University of Medical Science, Hezarjrib Street, Isfahan City Isfahan Isfehan Iran (Islamic Republic of)