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IRCT20160516027929N8 IRCT 2021-03-02 Shahid Beheshti University of Medical Sciences Evaluation of the effectiveness of high flow oxygen delivery through the nasal cannula in comparison with non-invasive ventilation in patients with COVID-19 Evaluation of the effectiveness of high flow nasal cannula (HFNC) oxygen delivery in comparison with non-invasive ventilation (NIV) in patients with COVID-19 2020-06-21 anticipated 60 Complete https://irct.ir/trial/53646 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: With simple randomization and using a random number table and individual randomization unit. To randomize, we use a table consisting of random digits 0 to 9. Each digit of this table is repeated the same on average. There is no pattern of recognizable numbers. In this method, each number is assigned to a treatment group. We start from the first line of the table and move down line by line. For the two treatments, we put the numbers 0 to 4 for treatment A and the numbers 5 to 9 for treatment B. The numbers in the first line of the table are as follows: 0,5,2,7,8,4,3,7,4,1,6,8,3,8,5,1,5,6,9,6, ... Now for people based on the above numbers, we have the following allocation: A, B, A, B, B,... We will continue the above process until the two groups are completed, Blinding description: To prevent any possible complications, the primary caregiver is aware of the allocation of treatment groups. Patients in the study were also not blinded to the treatment they were receiving. Researchers responsible for data collection and analysis are not aware of the allocation of different study groups. N/A COVID-19. Intervention 1: Intervention group: Before starting oxygen therapy, patients undergo treatment approved by the Ministry of Health. Oxygen therapy of patients is performed during the period of receiving Remdesivir. Before starting oxygen therapy, clinical examination and analysis of arterial blood gases in these patients will be on the agenda. Oxygen delivery to the patient with the high flow nasal cannula is then done (a device with Fisher & Paykel model) for 24 hours. Flow and temperature are adjusted according to the patient's satisfactory breathing. After 24 hours and in the next stage, 48 hours after the start of oxygenation, patients' clinical manifestations and ABG results will be evaluated. Intervention 2: Intervention group: In the second group, as in the first group, patients undergo treatment approved by the Ministry of Health. During the period of receiving Remdesivir, non-invasive ventilation is on the agenda. Before starting oxygen therapy, the clinical condition and arterial blood gas analysis of these patients will be reviewed.24 hours after non-invasive ventilation and in the next stage, 48 hours after the onset of oxygenation, clinical symptomes and ABG results of patients will be evaluated. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more informationn
public Atefeh Fakharian
Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran), Tehran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2000 fakharian_2005@yahoo.com Shahid Beheshti University of Medical Sciences scientific Atefeh Fakharian
Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran), Tehran
Tehran Iran (Islamic Republic of) 19569444413 +98 21 2712 2000 fakharian_2005@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Arterial blood oxygen saturation less than 90% Signing a written consent to participate in the study Age over 18 years 18 years no limit Both Pulmonary insufficiency Acute or chronic renal failure Pregnancy or breastfeeding Acute heart failure B34.2 Coronavirus infection, unspecified Treatment - Devices Treatment - Devices Intervention group: Before starting oxygen therapy, patients undergo treatment approved by the Ministry of Health. Oxygen therapy of patients is performed during the period of receiving Remdesivir. Before starting oxygen therapy, clinical examination and analysis of arterial blood gases in these patients will be on the agenda. Oxygen delivery to the patient with the high flow nasal cannula is then done (a device with Fisher & Paykel model) for 24 hours. Flow and temperature are adjusted according to the patient's satisfactory breathing. After 24 hours and in the next stage, 48 hours after the start of oxygenation, patients' clinical manifestations and ABG results will be evaluated. Intervention group: In the second group, as in the first group, patients undergo treatment approved by the Ministry of Health. During the period of receiving Remdesivir, non-invasive ventilation is on the agenda. Before starting oxygen therapy, the clinical condition and arterial blood gas analysis of these patients will be reviewed.24 hours after non-invasive ventilation and in the next stage, 48 hours after the onset of oxygenation, clinical symptomes and ABG results of patients will be evaluated. Partial pressure of carbon dioxide. Timepoint: Before the intervention, 24 hours after the intervention and 48 hours after the intervention. Method of measurement: Through blood sampling and blood gas analysis. Oxygen saturation. Timepoint: Before the intervention, 24 hours after the intervention and 48 hours after the intervention. Method of measurement: Through blood sampling and blood gas analysis. Shahid Beheshti University of Medical Sciences Approved 2021-01-11 Ethics committee of Shahid Beheshti University of Medical Science Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran) Tehran Tehran Iran (Islamic Republic of)