NCT07381686

High-Flow Nasal Cannula Versus Noninvasive Ventilation After Extubation in Patients With COPD and Mild Hypercapnic Respiratory Failure

High-Flow Nasal Cannula Versus Noninvasive Ventilation After Extubation in Patients With COPD and Mild Hypercapnic Respiratory Failure: A Prospective, Randomized Comparative Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of hospital admissions and respiratory intensive care unit (RICU) stays worldwide. After invasive mechanical ventilation, many COPD patients experience difficulty in the weaning process, with a high hazard of extubation failure due to persistent hypercapnia and weakened respiratory muscle function (1). Extubation failure is allied with increased morbidity, prolonged ICU stay, and higher mortality (2). Thus, effective post-extubation respiratory support strategies are central for improving outcomes in this susceptible group. Conventionally, noninvasive ventilation (NIV) has been the standard of care after extubation in COPD patients with mild to moderate hypercapnic respiratory failure, as it decreases work of breathing, improves gas exchange, and lowers reintubation rates (4). Though, NIV can be poorly tolerated due to mask-related discomfort, skin breakdown, claustrophobia, and patient-ventilator asynchrony (4).These limits often lead to suboptimal adherence and may compromise its efficacy in practice. High-flow nasal cannula (HFNC) oxygen therapy has arisen as another, offering heated and humidified oxygen at high flows, which provides low-level positive airway pressure, washes out nasopharyngeal dead space, and improves patient comfort (5). Recent trials suggest that HFNC may be non-inferior to NIV in preventing post-extubation respiratory failure in high-risk populations (6). Yet, data specifically addressing COPD patients with mild hypercapnic respiratory failure remain inadequate, and no agreement exists regarding the optimal strategy in this subgroup. Thus, a direct comparative study between HFNC and NIV in this context is reasonable to guide clinical practice (7).

Detailed description

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of hospital admissions and respiratory intensive care unit (RICU) stays worldwide. After invasive mechanical ventilation, many COPD patients experience difficulty in the weaning process, with a high hazard of extubation failure due to persistent hypercapnia and weakened respiratory muscle function (1). Extubation failure is allied with increased morbidity, prolonged ICU stay, and higher mortality (2). Thus, effective post-extubation respiratory support strategies are central for improving outcomes in this susceptible group. Conventionally, noninvasive ventilation (NIV) has been the standard of care after extubation in COPD patients with mild to moderate hypercapnic respiratory failure, as it decreases work of breathing, improves gas exchange, and lowers reintubation rates (4). Though, NIV can be poorly tolerated due to mask-related discomfort, skin breakdown, claustrophobia, and patient-ventilator asynchrony (4).These limits often lead to suboptimal adherence and may compromise its efficacy in practice. High-flow nasal cannula (HFNC) oxygen therapy has arisen as another, offering heated and humidified oxygen at high flows, which provides low-level positive airway pressure, washes out nasopharyngeal dead space, and improves patient comfort (5). Recent trials suggest that HFNC may be non-inferior to NIV in preventing post-extubation respiratory failure in high-risk populations (6). Yet, data specifically addressing COPD patients with mild hypercapnic respiratory failure remain inadequate, and no agreement exists regarding the optimal strategy in this subgroup. Thus, a direct comparative study between HFNC and NIV in this context is reasonable to guide clinical practice (7).

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Non-Invasive Ventilation (NIV)	In the NIV group, a BiPAP machine will be used with an oronasal mask, adjusting inspiratory and expiratory pressures based on patient tolerance and ABG results.
DEVICE	High-Flow Nasal Cannula (HFNC)	Patients assigned to the HFNC arm will receive oxygen through a high-flow nasal cannula connected to a heated humidifier, with flow rates titrated up to 60 L/min and FiO₂ adjusted to maintain target oxygen saturation (88-92%).

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-30
• Completion: 2026-11-30
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: Egypt