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

NCT06996834 | Recruiting

• 1 other identifier: 307052025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Community-Acquired Infections; Community-acquired Pneumonia

Keywords

CAP; NIV; HVNI

Outcome Measures

Primary Outcomes (1)

• Treatment Failure Within 48 Hours

  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.

  48 hours after randomization

Study Arms (2)

Non-Invasive Ventilation (NIV)

EXPERIMENTAL

Intervention: Participants in this arm will receive non-invasive 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 community-acquired pneumonia (CAP).

Device: Non-Invasive ventilation (NIV)

High velocity nasal insufflation (HVNI)

EXPERIMENTAL

Intervention: 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).

Device: High Velocity Nasal Insufflation

Interventions

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.

Also known as: BI-level Positive airway pressure ventilation (BIPAP)

Non-Invasive Ventilation (NIV)

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).

Also known as: High velocity nasal cannula, Vapotherm delivery system

High velocity nasal insufflation (HVNI)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, Assuit, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia; Community-Acquired Infections

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ahmad M. Shaddad, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Aliae A. Hussien, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad M. Shaddad, MD

CONTACT

+0201111171930; shaddad_ahmad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label trial wherein participants, care providers, and investigators are aware of the assigned interventions. To minimize assessment bias, outcome assessors responsible for evaluating primary and secondary endpoints will remain blinded to treatment allocations throughout the study duration.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study is designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either high-velocity nasal insufflation (HVNI) or noninvasive ventilation (NIV). Each participant will remain in their assigned intervention group for the duration of the study. The primary objective is to compare the efficacy of HVNI versus NIV in managing acute exacerbations of community-acquired pneumonia (CAP) by assessing treatment failure rates within 48 hours, defined as the need for intubation or death. Secondary outcomes include changes in gas exchange parameters, patient comfort levels, ICU length of stay, and 28-day mortality rates.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be accessible 6-36 months after publication
• Access Criteria: Data will be accessible 6-36 months after publication to qualified researchers upon submission of a study proposal, approval by the University Research Ethics Committee, and execution of a data-use agreement.

Locations

EG (1)