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IRCT20200612047740N4 IRCT 2022-06-18 Artesh University of Medical Sciences The effect of esophageal pressure measurement to prevent pulmonary barotrauma in patients with Covid 19 undergoing respiratory support Evaluation of the effect of esophageal pressure measurement for non-invasive positive pressure ventilation (NIPPV) regulation for the prevention of pulmonary barotrauma in comparison with control group in patients with Covid 19 undergoing respiratory support admitted to the intensive care unit 2022-06-21 anticipated 90 Complete https://irct.ir/trial/60038 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to the groups of A and B using Randomization software (https://www.randomizer.org/) according to inclusion criteria. Each group has 45 members. In this software, numbers from 1 to 90 are entered into the software and at one time, they randomly pick the numbers from one to ninety so that the number of people in each group is equal. The numbers remain hidden and the order in which people enter the study is revealed in the order in which the data output software is displayed, and if the number is between 1 and 45, it is placed in the first group and if it is between 46 and 90, it is placed in the second group, Blinding description: Patients are divided into two groups A and B and are kept in two separate parts. How to do the study for each group is described. The information is collected by the clinical caregiver and the researcher and data analyzer do not know the patient group and after analyzing the data, the codes are decoded to avoid bias. 3 COVID-19. Intervention 1: Intervention group: Patients's nasogastric tube is pulled up and connected to a manometer and their intraesophageal pressure is measured. Ventilation settings are adjusted so that the difference in pulmonary pressure remains between 0-10 cm of water and if it is more than 35 to 40 cm of water, the settings of the device are reduced and no trauma occurs. Finally, the incidence of barotrauma in this group is measured. Intervention 2: Control group: Patients in this group do not have daily intraesophageal pressure measurements. Ventilation settings of patients in this group are controlled through anesthesia instructions set by the anesthesiologist (project manager) and the incidence of barotrauma in this group is measured. Yes - There is a plan to make this available What will be shared: Only registered symptoms can be published without mentioning the names of the participants When: Start of access period 6 months after printing the results up to one year after printing To whom: Only available to scholars working in academia and academia Conditions: Written request via email(hossein.naderi1374@gmail.com) and university approval Where to obtain: By contacting the corresponding author How to obtain: After the email is received by the applicant, it takes one week to agree The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days. Comments:
public Hossein Naderi
AJA University of medical sciences, Shahid Etemadzade st, West Fatemi
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 hossein.naderi1374@gmail.com Artesh University of Medical Sciences scientific Hossein Naderi
AJA University Of Medical Sciences, Shahid Etemadzade st, West Fatemi
Tehran Iran (Islamic Republic of) 1411718541 +98 31 3568 5233 hossein.naderi1374@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Patients with Covid 19 with positive PCR or CT scan Hospitalized in the intensive care unit Patient is receiving non-mechanical ventilation Patient should be fed through the gastric feeding tube (NG tube) Informed consent of the patient or his legal guardian no limit no limit Both Coagulation disorders Gastrointestinal bleeding History of fractures and trauma to the base of the skull U.07 COVID-19 Disease Prevention Prevention Intervention group: Patients's nasogastric tube is pulled up and connected to a manometer and their intraesophageal pressure is measured. Ventilation settings are adjusted so that the difference in pulmonary pressure remains between 0-10 cm of water and if it is more than 35 to 40 cm of water, the settings of the device are reduced and no trauma occurs. Finally, the incidence of barotrauma in this group is measured. Control group: Patients in this group do not have daily intraesophageal pressure measurements. Ventilation settings of patients in this group are controlled through anesthesia instructions set by the anesthesiologist (project manager) and the incidence of barotrauma in this group is measured. Intra esophageal pressure. Timepoint: Intraesophageal pressure is measured twice daily (morning and evening) while receiving non-invasive ventilation while the patient is in the intensive care unit(ICU). Method of measurement: Manometer. Number of people with barotrauma. Timepoint: From the start of non-invasive ventilation to the onset of barotrauma. Method of measurement: Observe and record. Oxygen saturation. Timepoint: It is measured twice daily (morning and evening) while receiving non-invasive ventilation while the patient is in the intensive care unit(ICU). Method of measurement: Pulse oximeter. Duration of stay in the intensive care unit. Timepoint: From the time of entering the intensive care unit until the time of discharge or the time of death. Method of measurement: Observe and record. Trans pulmonary pressure. Timepoint: Trans pulmonary pressure is measured twice daily (morning and evening) while receiving non-invasive ventilation while the patient is in the ICU. Method of measurement: Manometer. Time of barotrauma. Timepoint: Number of days from the start of non-invasive ventilation to the onset of barotrauma. Method of measurement: Observe and record. Artesh University of Medical Sciences Approved 2022-02-20 Ethics committee of AJA University of Medical AJA university of medical sciences, Shahid Etemadzade st, West Fatemi st Tehran Tehran Iran (Islamic Republic of)