COPDOPTIMUS-MASKNCT07081776
Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe COPD Exacerbation Requiring Non-Invasive Mechanical Ventilation
A study testing OptiNIV and Visairo in people with COPD and Respiratory Acidosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Respiratory Acidosis
- What is being tested?
- OptiNIV and Visairo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
U.O Pneumologia e Terapia Intensiva Respiratora, IRCCS AOU di Bologna
Bologna, Bologna, 40138
Lara Pisani, MD, +39 0512143257, lara.pisani@unibo.it
About this study
Official title: Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe Exacerbation of COPD Requiring Non-Invasive Mechanical Ventilation: A Single-Center, Exploratory, Randomized Cross-Over Study
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).
Read the 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
- Being tested
- OptiNIV, Visairo
- Keywords
- COPD, NIV, Oronasal Mask, PaCO2
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiNIVDevice
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.
VisairoDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| OptiNIV | Experimental | Patients will undergo treatment with the OptiNIV Mask Receives: Device: OptiNIV |
| Visairo | Active comparator | Patients will undergo treatment with Visairo Mask Receives: Device: Visairo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Secondary outcomes (17)
Evaluation of changes in paO2
It will be measured through arterial blood gas analysis Unit of measuremet: mmHg
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in HCO3-
It will be measured through arterial blood gas analysis
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in pH
It will be measured through arterial blood gas analysis
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in PaO₂/FiO₂
It will be measured through arterial blood gas analysis
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in blood pressure
It will be measured using a sphygmomanometer Unit of measuremet: mmHg
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the heart rate
It will be measured using a pulsoximeter Unit of measuremet: bpm
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the respiratory pattern
It will be measured using the Minute Ventilation data and Respiratory Rate data obtained through a respiratory inductance plethysmography
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the Ventilatory Ratio
It will be measured using the formula VR = (minute ventilation [ml/min] × PaCO₂) / (predicted weight [kg] × 100 × 37.5).
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the end-tidal carbon dioxide (etCO₂)
It will be measured using a capnograph
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the esophageal pressure swing
It will be measured via a nasogastric tube with an esophageal balloon.
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the asynchrony index
It will be measured using the formula: AI = number of asynchronies / RR x 100 and will be measured by downloading the ventilator data at the end of each session
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in transcutaneous SpO₂ %
Will be measured via transcutaneous monitoring of SpO₂ that will be performed using a dedicated device that will record data for the entire duration of the study. Data at the end of each session will be compared with the data obtained at the beginning of the session.
Unit of measure: %
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in transcutaneous TcCO2
Will be measured via transcutaneous monitoring of TcCO2 that will be performed using a dedicated device that will record data for the entire duration of the study. Data at the end of each session will be compared with the data obtained at the beginning of the session.
Unit of measure: mmHg
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of dyspnea
It will be measured using a visual analog scale (VAS) ranging from 0 to 100 where 0 represents minimum dyspnea and 100 represents maximum dyspnea
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of the comfort level experienced
It will be measured using a visual analog scale (VAS) with a score ranging from 0 to 10, where 0 represents maximum comfort and 10 represents maximum discomfort.
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of NIV failure
NIV failure will be measured as the need for invasive mechanical ventilation (IMV)
Measured: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Occurrance of adverse events
will be measured by recording any complications (skin irritation or ulcers, gastric distension, pneumothorax, hypotension, conjunctivitis, claustrophobia, aspiration) that occur during sessions with the two interfaces
Measured: T1 ( + 1 hour) and at T3 (+ 3 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081776
- Sponsor's protocol ID
- OPTIMUS-MASK
- Acronym
- OPTIMUS-MASK
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35349909Charususin 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.
PubMed 29072087Rochwerg 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.
PubMed 28860265
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe Exacerbation of COPD Requiring Non-Invasive Mechanical Ventilation: A Single-Center, Exploratory, Randomized Cross-Over Study
- ClinicalTrials.gov ID
- NCT07081776
- Acronym / sponsor ID
- OPTIMUS-MASK / OPTIMUS-MASK
- Conditions
- COPD, Respiratory Acidosis
- Keywords
- COPD, NIV, Oronasal Mask, PaCO2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- University of Bologna, Fisher and Paykel Healthcare
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OptiNIV | Experimental | Device: OptiNIVPatients will undergo treatment with the OptiNIV Mask |
| Visairo | Active comparator | Device: VisairoPatients will undergo treatment with Visairo Mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptiNIVPatients 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 | OptiNIV |
| VisairoPatients 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. | Device | Visairo |
Primary outcome
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.
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Measured through arterial blood gas analysis. Unit of measurement: mmHg
17 secondary outcomes
Evaluation of changes in paO2
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in HCO3-
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in pH
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in PaO₂/FiO₂
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in blood pressure
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the heart rate
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the respiratory pattern
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the Ventilatory Ratio
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the end-tidal carbon dioxide (etCO₂)
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the esophageal pressure swing
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in the asynchrony index
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in transcutaneous SpO₂ %
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of changes in transcutaneous TcCO2
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of dyspnea
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of the comfort level experienced
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Evaluation of NIV failure
Time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).
Occurrance of adverse events
Time frame: T1 ( + 1 hour) and at T3 (+ 3 hours).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 35349909Piquilloud 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.
- Background: PubMed 29072087Charususin 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.
- Background: PubMed 28860265Rochwerg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptiNIV and Visairo in people with COPD and Respiratory Acidosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara Pisani, MD (+39 0512143257, lara.pisani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: T0 (baseline), T1 ( + 1 hour), T2 ( + 2 hours), T3 (+ 3 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07081776, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.