Chronic Obstructive Pulmonary DiseaseCODUETNCT05528289
Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients
A study testing AIRVO 2, with conventional symmetric nasal cannula and AIRVO 2, the new asymmetric nasal cannula in people with Chronic Obstructive Pulmonary Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been expanded also in other specific settings In stable COPD patients and in those recovering from acute exacerbation, HFNC can reduce PaCO2, respiratory rate, minute ventilation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AIRVO 2, with conventional symmetric nasal cannula and AIRVO 2, the new asymmetric nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 4 Aug 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Inpatients recovering from an acute exacerbation of their disease
- Persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH>7,35 and
- PaCO2>50 mmHg on 3 consecutive measurements)
- Informed consent
Who cannot join
- Body Mass Index (BMI) > 30 kg/m2;
- Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
- Chest wall disease
- Heart failure
- Severe hemodynamic instability ( need for amine support)
- Acute coronary syndrome (ACS)
Show all 12Show fewer
- Severe arrhythmia
- Renal insufficiency
- Patients unable to protect respiratory airways
- Respiratory arrest and need for endotracheal intubation
- Pregnancy
- Need for sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients With Persistent Hypercapnia Following an Acute Severe Exacerbation
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been expanded also in other specific settings In stable COPD patients and in those recovering from acute exacerbation, HFNC can reduce PaCO2, respiratory rate, minute ventilation and respiratory effort.
The aim of this randomized crossover physiological study is to investigate the effects on PaCO2 levels of two different nasal cannula ('Optiflow + Duet' interface vs "standard" nasal interface) in COPD patients with persistent hypercapnia following an acute severe exacerbation
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- AIRVO 2, with conventional symmetric nasal cannula, AIRVO 2, the new asymmetric nasal cannula
- Keywords
- HFNC, Hypercapnia, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRVO 2, with conventional symmetric nasal cannulaDevice
Also called standard cannula
The patients will be asked to breathe with HFNC at flow of 40 L/min with the standard cannula
The size of nasal cannula will be selected to occlude patient's nostril of about 2/3.
Temperature will be set according to the patient's tolerance starting from 31°C, up to 37°C, while FiO2 is adjusted to maintain SpO2 between 88 and 92%.
AIRVO 2, the new asymmetric nasal cannulaDevice
Also called "Optiflow+ Duet"
The patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula
The size of nasal cannula will be selected to occlude patient's nostril of about 2/3.
Temperature will be set according to the patient's tolerance starting from 31°C, up to 37°C, while FiO2 is adjusted to maintain SpO2 between 88 and 92%.
| Study group | Role | What they receive |
|---|---|---|
| HFNC 40 L/min with conventional symmetric nasal cannula | Active comparator | The patients will be asked to breathe with HFNC at flow of 40 L/min with standard interface Receives: Device: AIRVO 2, the new asymmetric nasal cannula |
| HFNC 40 L/min with new asymmetric nasal cannula | Active comparator | The patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula Receives: Device: AIRVO 2, with conventional symmetric nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the partial pressure of carbon dioxide (PaCO2) levels
Arterial Blood Gases will be analyzed from a sample taken from the arterial artery
Measured: immediately after intervention
Secondary outcomes (7)
Respiratory Rate ( RR), (b/min)
This parameter will be measured by a bioelectrical impedance monitor and a single-use Pad Set sensor that will be placed on the surface of the chest wall (ExSpiron, Respiratory Motion) Inc. USA)
Measured: 90 minutes
Tidal Volume ( TV), (mL)
This parameter will be measured by a bioelectrical impedance monitor and a single-use Pad Set sensor that will be placed on the surface of the chest wall (ExSpiron, Respiratory Motion) Inc. USA)
Measured: 90 minutes
Minute Ventilation (VE), (L/min)
This parameter will be measured by a bioelectrical impedance monitor and a single-use Pad Set sensor that will be placed on the surface of the chest wall (ExSpiron, Respiratory Motion) Inc. USA)
Measured: 90 minutes
Inspiratory effort quantification
Esophageal pressure assessment through dedicated esophageal pressure transducer ( (Marquat Genie Biomedical,France)
Measured: 90 minutes
Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)
TcPCO2 and SpO2 will be recorded by using a dedicated device (SenTec AG, Therwil, Switzerland)
Measured: 90 minutes
Dyspnea score
Dyspnea will be recorded using the Borg scale that is a numeric scale where 0 is no dyspnea and 10 the maximal dyspnea that a patient can imagine
Measured: immediately after intervention
Comfort
this will be assessed by using the Visual Numerical Scale ranging between 1 (extreme discomfort) and 5 (very comfortable),
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start4 Aug 2022
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528289
- Sponsor's protocol ID
- n° 174/2022/Disp/AOUBo
- Acronym
- CODUET
- Status last verified
- Jun 2024
- First submitted
- 9 Aug 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients With Persistent Hypercapnia Following an Acute Severe Exacerbation
- ClinicalTrials.gov ID
- NCT05528289
- Acronym / sponsor ID
- CODUET / n° 174/2022/Disp/AOUBo
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- HFNC, Hypercapnia, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 6 Sep 2022 (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.
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been expanded also in other specific settings In stable COPD patients and in those recovering from acute exacerbation, HFNC can reduce PaCO2, respiratory rate, minute ventilation and respiratory effort.
The aim of this randomized crossover physiological study is to investigate the effects on PaCO2 levels of two different nasal cannula ('Optiflow + Duet' interface vs "standard" nasal interface) in COPD patients with persistent hypercapnia following an acute severe exacerbation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC 40 L/min with conventional symmetric nasal cannula | Active comparator | Device: AIRVO 2, the new asymmetric nasal cannulaThe patients will be asked to breathe with HFNC at flow of 40 L/min with standard interface |
| HFNC 40 L/min with new asymmetric nasal cannula | Active comparator | Device: AIRVO 2, with conventional symmetric nasal cannulaThe patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatients recovering from an acute exacerbation of their disease
- Persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH>7,35 and
- PaCO2>50 mmHg on 3 consecutive measurements)
- Informed consent
Key exclusion criteria (12 listed)
- Body Mass Index (BMI) > 30 kg/m2;
- Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
- Chest wall disease
- Heart failure
- Severe hemodynamic instability ( need for amine support)
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 |
|---|---|---|
| AIRVO 2, with conventional symmetric nasal cannulaAlso: standard cannulaThe patients will be asked to breathe with HFNC at flow of 40 L/min with the standard cannula The size of nasal cannula will be selected to occlude patient's nostril of about 2/3. Temperature will be set according to the patient's tolerance starting from 31°C, up to 37°C, while FiO2 is adjusted to maintain SpO2 between 88 and 92%. | Device | HFNC 40 L/min with new asymmetric nasal cannula |
| AIRVO 2, the new asymmetric nasal cannulaAlso: "Optiflow+ Duet"The patients will be asked to breathe with HFNC at flow of 40 L/min with the new asymmetric nasal cannula The size of nasal cannula will be selected to occlude patient's nostril of about 2/3. Temperature will be set according to the patient's tolerance starting from 31°C, up to 37°C, while FiO2 is adjusted to maintain SpO2 between 88 and 92%. | Device | HFNC 40 L/min with conventional symmetric nasal cannula |
Primary outcome
Changes of the partial pressure of carbon dioxide (PaCO2) levels
Time frame: immediately after intervention
Arterial Blood Gases will be analyzed from a sample taken from the arterial artery
7 secondary outcomes
Respiratory Rate ( RR), (b/min)
Time frame: 90 minutes
Tidal Volume ( TV), (mL)
Time frame: 90 minutes
Minute Ventilation (VE), (L/min)
Time frame: 90 minutes
Inspiratory effort quantification
Time frame: 90 minutes
Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)
Time frame: 90 minutes
Dyspnea score
Time frame: immediately after intervention
Comfort
Time frame: immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIRVO 2, with conventional symmetric nasal cannula and AIRVO 2, the new asymmetric nasal cannula in people with Chronic Obstructive Pulmonary Disease, 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 21 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the partial pressure of carbon dioxide (PaCO2) levels (time frame: immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.