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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: High-Velocity Nasal Insufflation (HVNI); Device: Non-Invasive Ventilation (NIV)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Damanhūr, Egypt
    • Chest Hospital Damanhour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: High-Velocity Nasal Insufflation (HVNI); 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.
Active Comparator: 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.	Device: Non-Invasive Ventilation (NIV); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in arterial carbon dioxide (PaCO2)	Baseline and 1 hour after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		Up to 30 days
Need for escalation to invasive mechanical ventilation	Proportion of patients requiring invasive mechanical ventilation	Up to 4 days after randomization
Change in arterial pH from baseline to 24 hours after randomization		Baseline and 24 hours
Change from baseline in arterial carbon dioxide (PaCO₂)		Baseline to 24 hours after randomization
Change in arterial pH from baseline to 24 hours after randomization		Baseline and 24 hours after randomization
Change from baseline in respiratory rate		Baseline to 24 hours after randomization

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Eman Mostafa moazen, MD,PhD, Al-Azhar University, Faculty of Medicine; Principal Investigator: Entsar Sayed ahmed, MD,PhD, Faculty of Medicine al Azhar University; Study Director: Magd Mohamed Galal, MD, PhD, Faculty of Medicine al Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: April 18, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation
• Other Study ID Numbers: COPD-HVNI-NIV-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No