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IRCT20200611047727N4 IRCT 2021-04-28 Shahid Beheshti University of Medical Sciences Evaluation of the effect of high flow oxygen delivery under different temperatures in COVID-19 patients The effectiveness of oxygen delivery through high flow nasal cannula (HFNC) with different temperatures in improving the clinical symptoms of COVID-19 patients 2021-04-19 anticipated 30 Complete https://irct.ir/trial/55024 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: With simple randomization and using random number table and individual randomization unit. For randomization, we use a table consisting of random digits 1 to 9. Each digit of this table is repeated the same on average. There is no pattern of recognizable numbers. In this method, each figure is assigned to a treatment group. We start from the first row of the table and move from row to row. For the three treatments, we put the numbers 1 to 3 for treatment A, the numbers 4 to 6 for treatment B, and the numbers 7 to 9 for treatment C. We will continue the above process until the two groups are completed, Blinding description: To prevent any possible complications, the doctor and clinical caregiver are fully aware of the specificity of the treatment groups. Patients in the study were also not blinded to the type of treatment they were receiving. Researchers responsible for data collection and analysis are not aware of the allocation of different study groups. 2 COVID-19. Intervention 1: First intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 31 ° C. Intervention 2: Second intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 34 ° C. Intervention 3: Third intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 37 ° C. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Maryam Sadat Mirenayat
Masih Daneshvari Hospital, Darabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 mirenayat_m@yahoo.com Shahid Beheshti University of Medical Sciences scientific Maryam Sadat Mirenayat
Masih Daneshvari Hospital, Darabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 mirenayat_m@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) New coronavirus detection (clinical or paraclinical) Oxygen saturation less than 90% Written consent to participate in the study Age over 18 years Moderate to severe Covid-19 disease is hospitalized and requires respiratory support 18 years no limit Both PaCO2>65 PH<7.28 Cardiovascular disorders that prevent pulmonary rehabilitation U07.01 COVID-19 Treatment - Devices Treatment - Devices Treatment - Devices First intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 31 ° C. Second intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 34 ° C. Third intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 37 ° C. Oxygen saturation. Timepoint: Before starting oxygen therapy, 24 hours later. Method of measurement: Pulse oxymetry. Partial pressure of carbon dioxide. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: VBG analysis. Interleukin 6. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests. C-Reactive Protein. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests. Erythrocyte Sedimentation Rate. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests. Ferritin. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests. Borg scale. Timepoint: Before starting oxygen therapy, every day for a week. Method of measurement: Borg questionnaire. Shahid Beheshti University of Medical Sciences Approved 2021-03-08 Ethics Committee of Shahid Beheshti University of Medical Sciences Dr. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran) Tehran Tehran Iran (Islamic Republic of)