COPD Exacerbations, Acute Hypercapnic Respiratory Failure, Respiratory Failure
Conditions
Keywords
High-flow nasal cannula, Noninvasive ventilation, COPD exacerbations, efficacy, safety
Brief summary
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.
Detailed description
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.
Interventions
DEVICENIV
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.
DEVICEHFNC-30
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%.
DEVICEHFNC-50
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%.
Sponsors
Haseki Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
In this single-blind study, we assigned the participants randomly to one of three treatment groups using a computer-generated randomization program (SAS Institute, 1990). Each participant was assigned an identification number indicating their treatment group. An experienced clinician, who was blinded to the null hypothesis and did not participate in the evaluation of results, administered the treatments and recorded patient data on a pre-prepared case data form.
Intervention model description
Single center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- patients age ≥18 years with a confirmed diagnosis of COPD who presented to the ED with exacerbations that did not respond to bronchodilator therapy
Exclusion criteria
* patients aged younger than 18 years * patients had an arterial pH ≤ 7.25; * patients were in cardiopulmonary arrest; * patients had unstable cardiac arrhythmias or hemodynamic instability; * patients showed persistent hypoxemia despite supplemental oxygen therapy; * patients were unconscious or uncooperative; * patients could not protect their airway or manage secretions; * patients had cardiogenic pulmonary edema, active hemoptysis, pneumothorax, recent upper respiratory tract/esophagus surgery, significant airway obstruction (e.g., laryngeal mass or tracheal tumor), active upper gastrointestinal bleeding, or facial trauma or deformities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pH in arterial blood gas before vs. after treatment | 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. |
| Changes in PaCO2 in arterial blood gas before vs. after treatment | 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. |
| Changes in lactate in arterial blood gas before vs. after treatment | 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. |
| Changes in bicarbonate in arterial blood gas before vs. after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the need for rescue treatment and treatment-related complications | 120 minutes after initial treatment | The investigators assessed the need for invasive respiratory support and also evaluated treatment-related complications. |
Countries
Turkey (Türkiye)
Outcome results
None listed