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IRCT20160516027929N13 IRCT 2026-05-31 Shahid Beheshti University of Medical Sciences Comparison of the effectiveness of non-invasive ventilation and Venturi mask in patients with chronic obstructive pulmonary disease Comparison of the effect of Non-Invasive Ventilation (NIV) and Venturi mask on Impulse Oscillometry (IOS) parameters in hospitalized patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) 2026-07-23 anticipated 60 Pending https://irct.ir/trial/90350 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used is permuted block randomization. For this purpose, two treatment groups, A and B, are defined in blocks as AB and BA. Then, numbers from a random table in the range 0 to 9 are considered. Numbers 0 to 4 are assigned to block AB, and numbers 5 to 9 are assigned to block BA. Random numbers are then selected from the table. If the number 0 appears, it corresponds to block AB, and therefore two individuals enter this block, such that the first individual receives treatment A and the second individual receives treatment B. In the same way, the treatment groups for the remaining participants are determined. Although in this method the number of observations in both groups will be equal, because of the small block sizes, there is a high probability that the person conducting the study may predict the treatment group assignment. To solve this problem, the randomization list is prepared before the start of the study by a blinded individual who is not part of the treatment team. Additionally, the block sizes will be increased, Blinding description: To ensure blinding, patients are placed in separate rooms and are unaware of their group assignment. Additionally, the operator responsible for performing Impulse Oscillometry is different from the nurse who sets up the non-invasive ventilation or Venturi mask for the patient. This operator is blinded to the patient grouping during the Impulse Oscillometry test, which is conducted in a location separate from the intervention site. Furthermore, the data analyst will only have access to coded data (Group A and Group B) and will remain blinded to the nature of the groups until the end of the statistical analysis process. 3 Chronic obstructive pulmonary disease. Intervention 1: Intervention group: In the NIV group, patients are placed on non-invasive ventilation with an appropriate mask. The initial device settings will be standard as follows: IPAP: 10–14 cmH₂O EPAP: 4–6 cmH₂O FiO₂ adjustment with the goal of maintaining oxygen saturation (SpO₂) in the range of 88–92% Settings can be adjusted based on patient tolerance, reduction of dyspnea, and improvement of respiratory indices. Intervention 2: Intervention group: In the Venturi group, patients receive the required oxygen with the following settings: the percentage of the Venturi mask will be determined to maintain O2 saturation at 88 to 92. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Mohsen Sadeghi
Masih Daneshvari Hospital, Darabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 9946 doctormsadeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Hamidreza Jamaati
Masih Daneshvari Hospital, Darabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 2020 hrjamaai@hotmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) Dyspnea Oxygen saturation (SpO2) less than 88% on room air pH greater than or equal to 7.30 Partial pressure of carbon dioxide (PaCO2) greater than or equal to 45 mmHg in arterial blood gases (ABG) upon admission Appropriate level of consciousness (Glasgow Coma Scale 15) Ability to cooperate and perform Impulse Oscillometry test Informed consent to participate in the study no limit no limit Both Patient's unwillingness to participate in the research study J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Other Treatment - Other Intervention group: In the NIV group, patients are placed on non-invasive ventilation with an appropriate mask. The initial device settings will be standard as follows: IPAP: 10–14 cmH₂O EPAP: 4–6 cmH₂O FiO₂ adjustment with the goal of maintaining oxygen saturation (SpO₂) in the range of 88–92% Settings can be adjusted based on patient tolerance, reduction of dyspnea, and improvement of respiratory indices. Intervention group: In the Venturi group, patients receive the required oxygen with the following settings: the percentage of the Venturi mask will be determined to maintain O2 saturation at 88 to 92. Airway resistance at 5 Hz frequency (R5). Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Impulse Oscillometry. Airway resistance at 20 Hz frequency (R5). Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Impulse Oscillometry. Resistance heterogeneity level (R5–R20). Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Impulse Oscillometry. Input Impedance (X5). Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Impulse Oscillometry. Resonance frequency (Fres). Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Impulse Oscillometry. Resonance area (AX). Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Impulse Oscillometry. Oxygen saturation percentage. Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Pulse oximetry. Peripheral blood eosinophil. Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Counting of blood cells. Number of disease exacerbations. Timepoint: From the beginning of entering the study to the end of the study. Method of measurement: Self-expression. Blood acidity (pH). Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Venous Blood Gas Analysis. Bicarbonate. Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Venous Blood Gas Analysis. Partial pressure of carbon dioxide. Timepoint: Before the intervention (the first day of hospitalization) and after the intervention (on the fourth day). Method of measurement: Venous Blood Gas Analysis. Shahid Beheshti University of Medical Sciences Approved 2026-05-05 Ethics committee of School of Medicine, Shahid Beheshti University of Medical Sciences Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)