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IRCT20180129038542N1 IRCT 2020-04-13 The University of Baqiyatallah Early tracheostomy in COVID-19 The comparison between early tracheostomy and orotracheal intubation in critically ill COVID-19 patients. 2020-04-06 anticipated 30 Complete https://irct.ir/trial/47013 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The other similar studies are about the patients who required mechanical ventilation with many different conditions such as severe head trauma, acute respiratory distress syndrome, traumatic patients, etc. This is the first study about early tracheostomy and intubation in critically ill patients with COVID-19. N/A COVID-19. Intervention 1: Intervention group: Patients in this group received medications for the treatment of COVID-19 based on the Fifth Edition of the Novel Corona Virus Guidelines, in addition they indicated for mechanical ventilation and the airway management was selected using the tracheotomy tube within 3 days from intubation. Intervention 2: Control group: Patients in this group received medications for the treatment of COVID-19 based on the Fifth Edition of the Novel Corona Virus Guidelines, in addition they indicated for mechanical ventilation and the airway management was selected using the Orotracheal tube. Yes - There is a plan to make this available What will be shared: After the completion of the study, the information on the main outcome will be shared. When: 6 months after printing To whom: All researchers can take action. Conditions: Data and results will be available to all researchers for research on COVID-19. Where to obtain: Dr.najafi73@yahoo.com How to obtain: The data will be provided to the applicant after a review and approval of the request within a month. Comments:
public Shahriar Najafizadeh
No. 5, Mollasadra St., Vanak Sq., Baqiyatallah Hospital, Department of Surgery
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8216 2440 dr.najafi73@gmail.com Bagheiat-allah University of Medical Sciences scientific Shahriar Najafizadeh
Vanak Sq., Mollasadra St., Baqiyatallah University
Tehran Iran (Islamic Republic of) 141556437 +98 21 7735 6335 Dr.najafi73@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) The critically ill patients who were required mechanical ventilation no limit no limit Both U07.1 COVID-19 Treatment - Surgery Treatment - Devices Intervention group: Patients in this group received medications for the treatment of COVID-19 based on the Fifth Edition of the Novel Corona Virus Guidelines, in addition they indicated for mechanical ventilation and the airway management was selected using the tracheotomy tube within 3 days from intubation. Control group: Patients in this group received medications for the treatment of COVID-19 based on the Fifth Edition of the Novel Corona Virus Guidelines, in addition they indicated for mechanical ventilation and the airway management was selected using the Orotracheal tube. The oxygen blood saturation. Timepoint: Every 12 hours from the first day of hospitalization to the last day. Method of measurement: The pulse oximetry. Respiratory rate. Timepoint: 0-1-2-3-4-7-14 days after starting intervention. Method of measurement: Counting the number of breaths per minute. The mortality rate. Timepoint: 10, 20 days after starting intervention. Method of measurement: Counting deaths. Early Tracheotomy in COVID-19 Approved 2020-04-05 Ethics committee of Baqiyatallah University of Medical Sciences No.5, West Mollasadra st., Vanak Sq., Baqiyatallah Hospital, Department of Surgery Tehran Tehran Iran (Islamic Republic of)