High Velocity Nasal Insufflation Versus Non Invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure

NCT07561177 | Completed

• 1 other identifier: COPD-HVNI-NIV-2026
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Change in arterial carbon dioxide (PaCO2)

  Baseline and 1 hour after randomization

Secondary Outcomes (6)

• Need for escalation to 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

Study Arms (2)

HVNI group

EXPERIMENTAL

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)

NIV group

ACTIVE COMPARATOR

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)

Interventions

High-Velocity Nasal Insufflation (HVNI) DEVICE

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.

HVNI group

Non-Invasive Ventilation (NIV) DEVICE

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.

NIV group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Chest Hospital Damanhour

Damanhūr, 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

• Eman Mostafa moazen, MD,PhD

  Al-Azhar University, Faculty of Medicine

  STUDY DIRECTOR

• Entsar Sayed ahmed, MD,PhD

  Faculty of Medicine al Azhar University

  PRINCIPAL INVESTIGATOR

• Magd Mohamed Galal, MD, PhD

  Faculty of Medicine al Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist at Damanhur Chest Hospital

Model Details: Participants will be randomly assigned in a 1:1 ratio into two parallel groups: one receiving High-Flow Nasal Insufflation (HVNI) and the other receiving Non-Invasive Ventilation (NIV). Outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 1, 2026
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)