Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe COPD Exacerbation Requiring Non-Invasive Mechanical Ventilation

Summary

This single-center, crossover study aims to investigate the effects of the new OptiNIV oronasal mask used during NIV in COPD patients with respiratory acidosis following an exacerbation. The goal is to evaluate whether the clinical benefits, in terms of reducing PaCO2 levels, are greater with the new mask compared to a traditional one (Visairo Mask).

Conditions

• COPD
• Respiratory Acidosis

Interventions

DEVICE

OptiNIV

Patients assigned to the "OptiNIV" group will be submitted to two consecutive 60-minute sessions. In the first session, they will receive NIV with an "optimized" mask (OptiNIV) and in the second session they will receive NIV with a traditional" oronasal mask (Visairo). The study will follow a crossover design, meaning each patient will undergo both sessions, In both sessions, NIV will be delivered using the same ventilator (ASTRAL 150 - ResMed Europe). Ventilator settings will be set to ensure the most effective ventilation and the best comfort for each patient. However, these settings must remain unchanged during the two sessions. A 30-minute washout period is planned between the sessions, during which patients will receive traditional oxygen therapy through a Venturi mask. The 30 min wash-out periodod can be extended until PtCO₂ returns within ±2 mmHg of baseline or until 60 minutes have passed. The maximum total treatment time for each patient will be approximately 3 hours.

DEVICE

Visairo

Patients assigned to the "Visairo" group will be submitted to two consecutive 60-minute sessions. In the first session, they will receive NIV with a "traditional" oronasal mask (Visairo) and in the second session they will receive NIV with an "optimized" mask (OptiNIV). The study will follow a crossover design, meaning each patient will undergo both sessions. In both sessions, NIV will be delivered using the same ventilator (ASTRAL 150 - ResMed Europe). Ventilator settings will be set to ensure the most effective ventilation and the best comfort for each patient. However, these settings must remain unchanged during the two sessions. A 30-minute washout period is planned between the sessions, during which patients will receive traditional oxygen therapy through a Venturi mask. The 30 min wash-out periodod can be extended until PtCO₂ returns within ±2 mmHg of baseline or until 60 minutes have passed. The maximum total treatment time for each patient will be approximately 3 hours.

Sponsors & Collaborators

• University of Bologna

  collaborator OTHER

• Fisher and Paykel Healthcare

  collaborator INDUSTRY

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-31

Primary Completion

2026-10-31

Completion

2027-06-30

Countries

• Italy

Study Locations