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

NCT ID: NCT06996834

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-11-01

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.

Detailed Description

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.

Conditions

Community-acquired Pneumonia; Community-Acquired Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Non-Invasive Ventilation (NIV)

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).

Group Type: EXPERIMENTAL

Non-Invasive ventilation (NIV)

Intervention Type: 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.

High velocity nasal insufflation (HVNI)

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).

Group Type: EXPERIMENTAL

High Velocity Nasal Insufflation

Intervention Type: 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).

Interventions

Non-Invasive ventilation (NIV)

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.

Intervention Type: DEVICE

High Velocity Nasal Insufflation

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).

Intervention Type: DEVICE

Other Intervention Names

BI-level Positive airway pressure ventilation (BIPAP); High velocity nasal cannula; Vapotherm delivery system

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Shaddad

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad M. Shaddad, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Aliae A. Hussien, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assuit University

Asyut, Assuit, Egypt

Countries

Egypt

Central Contacts

Ahmad M. Shaddad, MD

Role: CONTACT

shaddad_ahmad@yahoo.com

+0201111171930

Facility Contacts

Ahmad M. Shaddad, MD

Role: primary

shaddad_ahmad@yahoo.com

+201111171930

Other Identifiers

307052025

Identifier Type: -

Identifier Source: org_study_id