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

NCT ID: NCT07081776

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-06-30

Brief 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).

Detailed Description

Non-invasive ventilation (NIV) is considered the gold standard treatment, in combination with medical therapy, for patients with respiratory acidosis secondary to Chronic Obstructive Pulmonary Disease (COPD). The choice of interface is a key factor in the success of NIV. A new oronasal mask, designed to improve CO2 washout (OptiNIV, Fisher & Paykel Healthcare, New Zealand), has recently been introduced to the market. Experimental data show that this interface, with a unique design separating airflow between the patient's mouth and nose, enhances gas flow at the end of expiration towards the oropharynx and subsequently out through the nostrils. This design facilitates the removal of CO2-rich air from the upper airways via dedicated ventilation ports located at the front of the mask, thereby optimizing CO2 clearance and dead space ventilation, which improves ventilatory efficiency.

This single-center, crossover study aims to investigate the effects of a new oronasal mask used during non-invasive ventilation (NIV) in COPD patients experiencing respiratory acidosis following an exacerbation. The objective is to assess whether the clinical benefits, specifically the reduction of PaCO₂ levels, are greater with the new mask compared to a traditional one. To minimize confounding factors affecting carbon dioxide washout, the new mask (OptiNIV, Fisher & Paykel Healthcare, New Zealand) will be compared to a mask of similar size, internal volume, and technical features (Visairo, Fisher & Paykel Healthcare, New Zealand), differing only in the presence of a separated airflow between the mouth and nose. This study holds significant clinical relevance, as no data are currently available on the use of the OptiNIV mask in patients with acute respiratory acidosis secondary to COPD exacerbation. The results could lead to optimized carbon dioxide clearance and improved ventilatory efficiency in managing patients with severe COPD exacerbations.

The study population consists of patients with respiratory acidosis secondary to COPD exacerbation who require non-invasive ventilation (NIV) and are admitted to the Respiratory and Critical Care Unit at the IRCCS AOU of Bologna, Policlinico S. Orsola. Patients meeting eligibility criteria will be randomly assigned (1:1) to two consecutive 60-minute NIV sessions using a traditional oronasal mask (Visairo) and an optimized mask (OptiNIV), following a crossover design. The sequence of mask use will be randomly assigned by the randomization list. NIV will be delivered with the same ventilator (ASTRAL 150 - ResMed Europe) using a single-limb circuit and pressure support mode, adjusting FiO₂ to maintain SpO₂ between 88-92%. Ventilator settings (IPAP, EPAP, triggers, rise time, Ti min, Ti max) will be set according to clinical practice but kept constant between sessions.

A 30-minute washout period with Venturi mask oxygen therapy will separate the two sessions, aiming to maintain SpO₂ between 88-92%. At the end of the washout, transcutaneous CO₂ (PtCO₂) will be measured; if this value is within ±2 mmHg of baseline, patient will proceed to the second session; otherwise, the washout will be extended up to 60 minutes. Including the washout, the total study duration per patient will not exceed 3 hours.

Conditions

COPD; Respiratory Acidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OptiNIV

Patients will undergo treatment with the OptiNIV Mask

Group Type: EXPERIMENTAL

OptiNIV

Intervention Type: DEVICE

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.

Visairo

Patients will undergo treatment with Visairo Mask

Group Type: ACTIVE_COMPARATOR

Visairo

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Informed consent obtained
• Patients with COPD and acute hypoxemic-hypercapnic respiratory failure (pH < 7.35, PaO₂ < 60 mmHg, PaCO₂ > 45 mmHg) requiring non-invasive mechanical ventilation.

Exclusion Criteria

• BMI ≥ 30 kg/m²
• Obstructive sleep apnea syndrome
• Neuromuscular diseases or chest wall pathologies
• Need for intubation and invasive mechanical ventilation during exacerbation
• Use of home non-invasive mechanical ventilation or CPAP
• Contraindications for NIV
• Cognitive disorders that may interfere with adherence to treatments
• Patients with active and unstable coronary artery disease
• Previous esophageal surgery, known esophageal stenosis, or any other condition that could put the patient at risk during the placement of the respiratory mechanics probe

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

Sponsors

University of Bologna

OTHER

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

dr. Stefano Nava

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

U.O Pneumologia e Terapia Intensiva Respiratora, IRCCS AOU di Bologna

Bologna, Bologna, Italy

Countries

Italy

Central Contacts

Lara Pisani, MD

Role: CONTACT

lara.pisani@unibo.it

+39 0512143257

Facility Contacts

Lara Pisani, MD

Role: primary

lara.pisani@unibo.it

+39 0512143257

References

Piquilloud L, Olivier PY, Richard JC, Thepot-Seegers V, Brochard L, Mercat A, Beloncle F. High flow nasal cannula improves breathing efficiency and ventilatory ratio in COPD patients recovering from an exacerbation. J Crit Care. 2022 Jun;69:154023. doi: 10.1016/j.jcrc.2022.154023. Epub 2022 Mar 26.

Reference Type: BACKGROUND

PMID: 35349909 (View on PubMed)

Charususin N, Dacha S, Gosselink R, Decramer M, Von Leupoldt A, Reijnders T, Louvaris Z, Langer D. Respiratory muscle function and exercise limitation in patients with chronic obstructive pulmonary disease: a review. Expert Rev Respir Med. 2018 Jan;12(1):67-79. doi: 10.1080/17476348.2018.1398084. Epub 2017 Nov 6.

Reference Type: BACKGROUND

PMID: 29072087 (View on PubMed)

Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.

Reference Type: BACKGROUND

PMID: 28860265 (View on PubMed)

Other Identifiers

OPTIMUS-MASK

Identifier Type: -

Identifier Source: org_study_id