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NCT Number: NCT06996834

Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia

This randomized controlled trial aims to compare the efficacy and safety of high-velocity nasal insufflation (HVNI) versus standard noninvasive ventilation (NIV) in adult patients experiencing acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure. The primary focus is on assessing treatment failure within 48 hours, defined as the need for intubation or death. Secondary outcomes include evaluations of gas exchange parameters, patient comfort levels, duration of ICU stay, and 28-day mortality rates.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuit University

Asyut, Assuit, 71515, Egypt

Location status: Recruiting

Location contact

Ahmad M. Abd El-hafeez, MD

SUB_INVESTIGATOR

Ahmad M. Shaddad, MD

CONTACT

[email protected]

+201111171930

Ahmad M. Shaddad, MD

PRINCIPAL_INVESTIGATOR

Aliae M. Hussien, MD

PRINCIPAL_INVESTIGATOR

Amal A. Abdullah, MD

SUB_INVESTIGATOR

About this study

Community-acquired pneumonia (CAP) is a significant contributor to acute hypoxemic respiratory failure, often necessitating ventilatory support. Noninvasive ventilation (NIV) has been a conventional approach; however, it can be associated with patient discomfort and varying success rates. High-velocity nasal insufflation (HVNI) presents an alternative, delivering heated and humidified oxygen at high flow rates, which may improve oxygenation and patient tolerance.

This study is designed as a prospective, randomized, open-label, parallel-group trial involving 100 adult patients diagnosed with CAP-induced hypoxemic respiratory failure. Participants will be randomly assigned to receive either high-volume non-invasive ventilation (HVNI) or non-invasive ventilation (NIV). The primary endpoint is treatment failure within 48 hours post-randomization, characterized by the necessity for endotracheal intubation or mortality. Secondary endpoints encompass changes in arterial blood gas measurements, patient-reported comfort scores, length of ICU stay, and 28-day mortality rates.

By systematically comparing HVNI and NIV in this patient population, the study seeks to determine whether HVNI offers a viable and potentially superior alternative to traditional NIV methods in managing acute respiratory failure due to CAP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Clinical and radiographic diagnosis of CAP
  • Respiratory failure using partial pressure of oxygen (PaO₂) and fraction of inspired oxygen (FiO₂) is defined by a partial pressure of oxygen/fraction of inspired oxygen ratio (PaO₂/FiO₂) ≤ 300 mmHg or a respiratory rate (RR) ≥ 25/min
  • Informed consent obtained

Exclusion criteria

  • Hemodynamic instability requiring vasopressors
  • Altered mental status Glasgow Coma Scale (GCS < 13)
  • Contraindication to NIV or HVNI (facial trauma, recent upper airway surgery)
  • Do-Not-Intubate (DNI) order

Treatment and study plan

Non-invasive ventilation (NIV)

Device

Participants in this arm will receive noninvasive ventilation using bilevel positive airway pressure (BiPAP) delivered via a full-face mask to support ventilation in patients with acute hypoxemic respiratory failure due to CAP.

Other names: BI-level Positive airway pressure ventilation (BIPAP)

High Velocity Nasal Insufflation

Device

Participants in this arm will receive high-velocity nasal insufflation therapy, a type of high-flow nasal cannula (HFNC) therapy that delivers heated and humidified oxygen at high flow rates to support patients with acute hypoxemic respiratory failure resulting from community-acquired pneumonia (CAP).

Other names: High velocity nasal cannula, Vapotherm delivery system

Primary outcomes

  1. Treatment Failure Within 48 Hours

    Time frame: 48 hours after randomization

    Treatment failure is defined as the occurrence of either endotracheal intubation or death within 48 hours following randomization. This composite endpoint assesses the immediate efficacy of the assigned respiratory support modality-High-Velocity Nasal Insufflation (HVNI) or Noninvasive Ventilation (NIV)-in preventing rapid clinical deterioration in patients with acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad M. Shaddad, MD

CONTACT

[email protected]

+0201111171930

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

A Randomized Controlled Trial of High-Velocity Nasal Insufflation (HVNI) Versus Noninvasive Ventilation (NIV) for Acute Respiratory Failure of Community-Acquired Pneumonia (CAP).

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 30, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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