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

NCT07081776 | Not Yet Recruiting

• 1 other identifier: OPTIMUS-MASK
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD; Respiratory Acidosis

Keywords

COPD; NIV; Oronasal Mask; PaCO2

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effects of the OptiNIV oronasal mask on partial pressure of carbon dioxide (PaCO₂) levels in patients with severe COPD exacerbation requiring treatment with non-invasive mechanical ventilation.

  Measured through arterial blood gas analysis. Unit of measurement: mmHg

  T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).

Secondary Outcomes (17)

• Evaluation of changes in paO2

  T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).

• Evaluation of changes in HCO3-

  T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).

• Evaluation of changes in pH

  T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).

• Evaluation of changes in PaO₂/FiO₂

  T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).

• Evaluation of changes in blood pressure

  T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).

Study Arms (2)

OptiNIV

EXPERIMENTAL

Patients will undergo treatment with the OptiNIV Mask

Device: OptiNIV

Visairo

ACTIVE COMPARATOR

Patients will undergo treatment with Visairo Mask

Device: Visairo

Interventions

OptiNIV 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.

OptiNIV

Visairo 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.

Visairo

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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

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

Bologna, Bologna, 40138, Italy

Location

Related Publications (3)

• 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.

  PMID: 35349909 BACKGROUND

• 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.

  PMID: 29072087 BACKGROUND

• 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.

  PMID: 28860265 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Acidosis, Respiratory

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Lara Pisani, MD

CONTACT

+39 0512143257; lara.pisani@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: July 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

IT (1)