High Velocity Nasal Insufflation Versus Non Invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure (HVNI vs NIV CO)
High-velocity Nasal Insufflation Versus Non-invasive Mechanical Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure
This study is a randomized clinical trial that compares two methods of non-invasive respiratory support in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated by acute hypercapnic respiratory failure.
Eligible adult patients admitted with this condition will be randomly assigned to receive either High-Flow Nasal Insufflation (HVNI) or Non-Invasive Ventilation (NIV).
The main goal of the study is to evaluate changes in blood gas levels, especially carbon dioxide (PaCO2), after one hour of treatment. Secondary outcomes include the need for invasive ventilation, length of hospital stay, changes in breathing rate, and in-hospital outcomes.
The study aims to determine whether HVNI can provide a safe and effective alternative to NIV in this group of patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a prospective randomized controlled trial conducted on adult patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated by acute hypercapnic respiratory failure (type II respiratory failure), admitted to the respiratory intensive care unit or emergency department.
COPD is a leading cause of morbidity and mortality worldwide, and acute exacerbations associated with hypercapnic respiratory failure represent a major cause of hospital admission and intensive care utilization. Non-invasive ventilation (NIV) is the standard of care in such cases; however, its use may be limited by patient intolerance, discomfort, and contraindications.
High-Flow Nasal Insufflation (HVNI) is an emerging non-invasive respiratory support modality that delivers heated, humidified oxygen at high flow rates, generating low levels of positive airway pressure, reducing dead space ventilation, and improving oxygenation and ventilation. It may offer improved patient comfort and tolerance compared to NIV.
In this study, eligible patients will be randomly assigned into two groups: Group I: High-Flow Nasal Insufflation (HVNI) Group II: Non-Invasive Ventilation (NIV) Baseline clinical data, arterial blood gases, and severity scores will be recorded. Patients will be monitored for clinical and laboratory response.
The primary endpoint is the mean difference in PaCO2 to evaluate the short-term effect of HVNI and NIV from baseline to one hour after randomization.
The secondary endpoints include the following outcomes:
Treatment change rates (switch to other ventilatory support modality due to clinical deterioration) Proportion of patients with PaCO2 worsening or reduction less than 10 mmHg from baseline, or no improvement in dyspnea Respiratory rate Changes in arterial blood gases Duration of mechanical ventilation (invasive and non-invasive) Length of hospital stay In-hospital mortality
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Damanhūr, Egipto
- Chest Hospital Damanhour
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Adults aged ≥18 years Diagnosis of acute exacerbation of COPD (AECOPD) Acute hypercapnic respiratory failure (PaCO2 > 45 mmHg with acidosis or indication for ventilatory support) Indication for non-invasive ventilatory support Hemodynamically stable patients Ability to provide informed consent or legal representative consent
Exclusion Criteria:
Age <18 years Immediate need for invasive mechanical ventilation (e.g., apnea, respiratory arrest, severe respiratory distress) Severe hypoxemia (PaO2 < 55 mmHg despite oxygen therapy) Severe acidosis (pH < 7.25) with hypercapnia Neuromuscular disease Unstable hemodynamics (SBP < 90 mmHg or MAP < 65 mmHg despite resuscitation) Hypercapnic respiratory failure due to non-COPD causes Contraindications to HVNI or NIV (facial trauma, obstruction, severe agitation, etc.) Pregnancy BMI > 30 kg/m²
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: HVNI group
Patients in this arm receive High-Velocity Nasal Insufflation (HVNI) as the primary non-invasive respiratory support modality for acute hypercapnic respiratory failure.
HVNI delivers heated and humidified oxygen at high flow rates to improve oxygenation, reduce work of breathing, and enhance patient comfort.
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High-velocity nasal insufflation delivering heated and humidified oxygen at high flow rates through nasal cannula.
It provides low level positive airway pressure, washout of anatomical dead space, reduction of work of breathing, and improvement in oxygenation and ventilation in patients with acute hypercapnic respiratory failure.
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Comparador activo: NIV group
Patients in this arm receive Non-Invasive Ventilation (NIV) as the standard non-invasive ventilatory support for acute hypercapnic respiratory failure.
NIV provides positive pressure ventilation via mask to improve alveolar ventilation, reduce PaCO2, and correct respiratory acidosis.
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Non-invasive ventilation delivered via face mask providing positive pressure support to improve alveolar ventilation, decrease PaCO2, correct respiratory acidosis, and reduce work of breathing in patients with acute hypercapnic respiratory failure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Change in arterial carbon dioxide (PaCO2)
Periodo de tiempo: Baseline and 1 hour after randomization
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Baseline and 1 hour after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duración de la estancia hospitalaria
Periodo de tiempo: Hasta 30 días
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Hasta 30 días
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Need for escalation to invasive mechanical ventilation
Periodo de tiempo: Up to 4 days after randomization
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Proportion of patients requiring invasive mechanical ventilation
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Up to 4 days after randomization
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Change in arterial pH from baseline to 24 hours after randomization
Periodo de tiempo: Baseline and 24 hours
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Baseline and 24 hours
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Change from baseline in arterial carbon dioxide (PaCO₂)
Periodo de tiempo: Baseline to 24 hours after randomization
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Baseline to 24 hours after randomization
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Change in arterial pH from baseline to 24 hours after randomization
Periodo de tiempo: Baseline and 24 hours after randomization
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Baseline and 24 hours after randomization
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Change from baseline in respiratory rate
Periodo de tiempo: Baseline to 24 hours after randomization
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Baseline to 24 hours after randomization
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Eman Mostafa moazen, MD,PhD, Al-Azhar University, Faculty of Medicine
- Investigador principal: Entsar Sayed ahmed, MD,PhD, Faculty of Medicine al Azhar University
- Director de estudio: Magd Mohamed Galal, MD, PhD, Faculty of Medicine al Azhar University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Condiciones Patológicas, Signos y Síntomas
- Enfermedad Pulmonar Obstructiva Crónica
- Terapéutica
- Gestión de las vías respiratorias
- Terapia respiratoria
- Respiración, artificial
- Ventilación no invasiva
Otros números de identificación del estudio
- COPD-HVNI-NIV-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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