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IRCT20160516027929N7 IRCT 2020-01-25 Shahid Beheshti University of Medical Sciences Comparison of the Efficacy of High-Flow Nasal Oxygen Therapy and Noninvasive Ventilation in patients with COPD Exacerbation Comparison of the Efficacy of High-Flow Nasal Oxygen Therapy and Noninvasive Ventilation in patients with COPD Exacerbation 2019-07-23 anticipated 68 Complete https://irct.ir/trial/40197 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Method of randomization: simple Unit of randomization : individual Tools used in randomization : table of random numbers Included patients, in a simple randomized evaluation using even and odd numbers, would got codes for each treatment group. In case of odd numbers, the patient would be enrolled in the group one to receive high flow oxygenation at the first stage and following a washout period, take noninvasive ventilation. On the other hand, patients gotten even numbers would receive noninvasive ventilation for the first stage. Then, after a washout period, high oxygen therapy would be prescribed, Blinding description: To treat any possible complications, the care provider is not blind. Other blind groups are as below: Participants, investigators, outcome assessor, Data analyse. N/A Chronic obstructive pulmonary disease (COPD). Intervention 1: Intervention group: Intervention group: First, ABG will be measured and then HFNT will be performed and after 1 hour, ABG will be measured again. Then 30 minutes will be passed without the device, after which ABG will be measured again. Eventually 1 hour NIV will be performed and ABG will be measured with the VPAP device. Intervention 2: Intervention group 2: First ABG will be measured and then the NIV will be performed, after 1 hour, ABG will be measured by the VPAP. Next 30 minutes will be without device and then ABG will be measured again. Then 1 hour HFNT will be done and ABG will be evaluated at the end. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Atefeh Fakharian
Masih Daneshvari Hospital, Darabad, Shahid Bahonar Ave, Tehran, Iran
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 Ave, Tehran. Iran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2000 fakharian_2005@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The presence of chronic obstructive pulmonary disease (COPD) and acute respiratory failure pH < 7.35 Arterial pressure of carbon dioxide (PaCO2) equal to or greater than 45mmHg 18 years no limit Both - Mechanical ventilation in the past 60 days (using any non-invasive ventilation or high blood oxygen through the nasal cannula (HFNT) prior to enrollment in the study and after the onset of acute upper respiratory failure (AHRF) - Non-invasive ventilation for home care - Undesirable clinical condition (require a vasopressor for> 24 hours, acute coronary syndrome or life-threatening arrhythmias ( - Refusal of treatment - Disorder in more than two organs -Heart failure - The respiratory tract requires a tracheal intubation - Trauma or burn in the neck and face - Pregnancy - Refusal of consent - enter to other research protocols J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Devices Treatment - Devices Intervention group: Intervention group: First, ABG will be measured and then HFNT will be performed and after 1 hour, ABG will be measured again. Then 30 minutes will be passed without the device, after which ABG will be measured again. Eventually 1 hour NIV will be performed and ABG will be measured with the VPAP device. Intervention group 2: First ABG will be measured and then the NIV will be performed, after 1 hour, ABG will be measured by the VPAP. Next 30 minutes will be without device and then ABG will be measured again. Then 1 hour HFNT will be done and ABG will be evaluated at the end. PaCO2. Timepoint: before intervention- one hour after - half hour after- after intervention. Method of measurement: ABG. SaO2. Timepoint: befor intervention-one hour after-half hour after- after intervention. Method of measurement: ABG. Shahid Beheshti University of Medical Sciences Approved 2019-06-01 Ethics committee of Shahid Beheshti of Medical Sciences Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran Tehran Tehran Iran (Islamic Republic of)