Acute Hypercapnic Respiratory FailureNCT03756415
CO2 Clearance During Noninvasive Ventilation (NIV)
A study testing DiMax Zero Total face mask "R", and traditional face mask in people with Acute Hypercapnic Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure
- What is being tested?
- DiMax Zero Total face mask "R", and traditional face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jun 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis
- sign inform consent
- able to tolerate the application of NIV
Who cannot join
- inability to tolerate the mask
- contraindication to NIV
- cancer, neurological diseases, and need of another life support besides the ventilator
Trial locations and contacts
No sites are listed yet.
vittoria comellini contact
About this study
Official title: Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask or the same mask with the addition of a new CO2 clearance device
Read the detailed description
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will undergo another 1 h trial using the other mask.
The subjects will be studied in the sitting position and asked to relax throughout the period of the study.
The patients will be ventilated using pressure support ventilation (PSV) The order of use of the two interfaces will be determined for each patient by a previously generated randomized sequence.
FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified throughout the study.
End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at -0.5 cm H2O.
Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between 6-8 mL/kg while avoiding occurrence of discomfort or visually assessed "wasted efforts".
The ventilatory settings will determined at the beginning of the first trial, and maintained unmodified throughout all the 3 runs.
Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be assessed by means of a scale used and validated in previous studies that is defined as follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by the respiratory therapist to answer the following question: "How do the patient feel your breathing is using this mask?" The patient will give the score to the therapist at the end of each run, just before ABG measurements.
- Conditions
- Acute Hypercapnic Respiratory Failure
- Being tested
- DiMax Zero Total face mask "R",, traditional face mask
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiMax Zero Total face mask "R",Device
a non-CO2 rebreathing device included directly in the full face mask
traditional face maskDevice
a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
| Study group | Role | What they receive |
|---|---|---|
| mask plus CO2 removal device | Experimental | a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R", Receives: Device: DiMax Zero Total face mask "R", |
| traditional face mask | Active comparator | Traditional mask without a CO2 clearance device inserted Receives: Device: traditional face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in arterial blood gases (ABGs)
Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
Measured: immediate
patient's tolerance to the mask
the tolerance will be recorded using an ad hoc scale
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- stefano nava, Principal investigator, Azienda Ospedaliera Sant'Orsola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756415
- Sponsor's protocol ID
- Stefano Nava1
- Status last verified
- Nov 2018
- First submitted
- 23 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allow to release individual data
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
- ClinicalTrials.gov ID
- NCT03756415
- Acronym / sponsor ID
- Stefano Nava1
- Conditions
- Acute Hypercapnic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 28 Nov 2018 (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.
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask or the same mask with the addition of a new CO2 clearance device
Detailed description
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will undergo another 1 h trial using the other mask.
The subjects will be studied in the sitting position and asked to relax throughout the period of the study.
The patients will be ventilated using pressure support ventilation (PSV) The order of use of the two interfaces will be determined for each patient by a previously generated randomized sequence.
FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified throughout the study.
End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at -0.5 cm H2O.
Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between 6-8 mL/kg while avoiding occurrence of discomfort or visually assessed "wasted efforts".
The ventilatory settings will determined at the beginning of the first trial, and maintained unmodified throughout all the 3 runs.
Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be assessed by means of a scale used and validated in previous studies that is defined as follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by the respiratory therapist to answer the following question: "How do the patient feel your breathing is using this mask?" The patient will give the score to the therapist at the end of each run, just before ABG measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mask plus CO2 removal device | Experimental | Device: DiMax Zero Total face mask "R",a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R", |
| traditional face mask | Active comparator | Device: traditional face maskTraditional mask without a CO2 clearance device inserted |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD diagnosis
- sign inform consent
- able to tolerate the application of NIV
Key exclusion criteria (3 listed)
- inability to tolerate the mask
- contraindication to NIV
- cancer, neurological diseases, and need of another life support besides the ventilator
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 |
|---|---|---|
| DiMax Zero Total face mask "R",a non-CO2 rebreathing device included directly in the full face mask | Device | mask plus CO2 removal device |
| traditional face maska traditional mask without a non-CO2 rebreathing device included directly in the full face mask | Device | traditional face mask |
Primary outcome
changes in arterial blood gases (ABGs)
Time frame: immediate
Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
patient's tolerance to the mask
Time frame: immediate
the tolerance will be recorded using an ad hoc scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No. not allow to release individual data
Related trials for Acute Hypercapnic Respiratory Failure
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Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)
Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia
Not yet recruiting
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis
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.
vittoria comellini contact
stefano nava principal investigator
Azienda Ospedaliera Sant'Orsola
Questions about this trial
What is this clinical trial studying?
A study testing DiMax Zero Total face mask "R", and traditional face mask in people with Acute Hypercapnic Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact stefano nava (3333751828, stefanava@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in arterial blood gases (ABGs) (time frame: immediate). The study lists 2 primary outcomes in all. 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 28 Nov 2018.