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

NCT07381686 | Active Not Recruiting

• 1 other identifier: HFNC vs NIV in COPD weaning
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COPD

Keywords

NIV,HFNC

Outcome Measures

Primary Outcomes (1)

• Extubation failure (need for reintubation within 72 hours).

  within 72 hours.

Study Arms (2)

NIV group

EXPERIMENTAL

using Non-Invasive Ventilation (NIV) as the intervention device, a BiPAP machine will be used with an oronasal mask, adjusting inspiratory and expiratory pressures based on patient tolerance and ABG results.

Device: Non-Invasive Ventilation (NIV)

HFNC group

EXPERIMENTAL

using High-Flow Nasal Cannula (HFNC) as intervention device, 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%).

Device: High-Flow Nasal Cannula (HFNC)

Interventions

Non-Invasive Ventilation (NIV) DEVICE

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.

NIV group

High-Flow Nasal Cannula (HFNC) DEVICE

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%).

HFNC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Severe acidosis or severe hypercapnia: pH \< 7.30 or PaCO₂ \> 60 mmHg requiring immediate escalation.
• Impending respiratory arrest or immediate need for re-intubation (severe hypoxemia, refractory distress, profound altered mental status).
• Severe hypoxemia not compatible with trial modalities (e.g., need for FiO₂ \> 0.8 or PEEP \> 10 cmH₂O to keep SpO₂ ≥ 88%).
• Hemodynamic instability: shock with rapidly escalating vasopressors, malignant arrhythmia, or active myocardial ischemia.
• Severe encephalopathy (GCS \< 13) or inability to protect airway.
• Massive hemoptysis, active upper GIT bleeding, or untreated pneumothorax.
• Post-extubation laryngeal edema/stridor requiring immediate re-intubation.
• Absolute/relative contraindications to NIV (mask-based): facial trauma/burns, recent facial/upper airway or gastric surgery, fixed upper airway obstruction, uncontrolled vomiting, severe agitation or mask intolerance.
• Contraindications to HFNC judged by the treating team (rare; e.g., complete nasal obstruction).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, أسيوط - Asyut Governorate, 71511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• montaser gamal ahmed

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

EG (1)