Haseki Training and Research Hospital
Istanbul, Fatih, 34265, Turkey (Türkiye)
NCT Number: NCT06495086
The investigators investigated the efficacy and safety of High Flow Nasal Cannula (HFNC) at different flow rates compared to non-invasive ventilation (NIV) in patients presenting to the emergency department (ED) with acute exacerbations of Chronic obstructive pulmonary disease (COPD) who did not respond adequately to bronchodilator therapy and continued to exhibit hypercapnic respiratory failure. Specifically, the investigators tested the hypothesis that HFNC would be more effective at reducing partial pressure of carbon dioxide (PaCO2) levels and hospital stay duration and would be associated with greater patient comfort than NIV.
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All sexes
Interventional
Not applicable
Istanbul, Fatih, 34265, Turkey (Türkiye)
The patients were divided randomly into one of three study groups: NIV, HFNC-30, and HFNC-50. The investigators collected patient data, including demographic characteristics (age and sex), vital signs upon admission (systolic blood pressure [SBP], respiratory rate [RR], and heart rate [HR]), complaints and symptoms upon admission, initial arterial blood gas parameters (e.g., pH, PaCO2, lactate, and bicarbonate), length of stay, ED revisits, patient satisfaction, intubation status, and clinical outcomes (hospitalization, admission to the intensive care unit [ICU], or 28-day mortality). Changes in arterial blood gas parameters (e.g., ΔpH, ΔPaCO2, Δlactate, and Δbicarbonate) before treatment vs. 30, 60, and 120 minutes after treatment were recorded using a pre-prepared case data form.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The NIV group received bilevel-positive airway pressure. During NIV, the tidal volume was set to 6-8 mL/kg, positive expiratory end pressure (PEEP) to 3-5 cm H2O, and pressure support ventilation (PSV) to 8-12 cm H2O by a clinician with 8 years of experience. To reduce potential bias, the clinician was blinded to the null hypothesis.
The HFNC-30 group received HFNC therapy at flow rates of 30 L/min. During HFNC, the humidifier was set to an open position, the heated air temperature was maintained at 37°C, and the FiO2 was adjusted to maintain an oxygen saturation (SpO2) measured via pulse oximetry of at least 92%.
The HFNC-50 group received HFNC therapy at flow rates of 50 L/min. During HFNC, the humidifier was set to an open position, the heated air temperature was maintained at 37°C, and the FiO2 was adjusted to maintain an oxygen saturation (SpO2) measured via pulse oximetry of at least 92%.
Time frame: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in pH before treatments vs. 30, 60, and 120 minutes after treatments.
Time frame: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in PaCO2 before treatments vs. 30, 60, and 120 minutes after treatments.
Time frame: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in lactate before treatments vs. 30, 60, and 120 minutes after treatments.
Time frame: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in bicarbonate before treatments vs. 30, 60, and 120 minutes after treatments.
Time frame: 120 minutes after initial treatment
The investigators assessed the need for invasive respiratory support and also evaluated treatment-related complications.
Haseki Training and Research Hospital
Other
A High-Flow Nasal Cannula Versus Noninvasive Ventilation in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Single-blind Randomized Trial
Acronym: HFNCstdy
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