Acute Hypoxemic Respiratory FailureDENOVTNCT04741659
Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure
A study testing Ventimask, High Flow Nasal cannula (HFNC) and Helmet CPAP in people with Acute Hypoxemic Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Ventimask, High Flow Nasal cannula (HFNC) and Helmet CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2021to 30 Jul 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Respiratory Failure (ARF) ( 100 <PaO2/FiO2 <300) due to Covid-19 infection
- Informed consent
- Enrollment within the first 24 hours after ARF
Who cannot join
- Clinical, radiological or istological evidence of chronic pulmonary disease.
- 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)
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- Acute coronary syndrome (ACS)
- Severe arrhythmia
- Patients unable to protect respiratory airways
- Respiratory arrest and need for endotracheal intubation
- Pregnancy
- Need for sedation
- Home long-term oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure Receiving Non-invasive Respiratory Supports: a Pilot Study
Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage in these patients.
The aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Ventimask, High Flow Nasal cannula (HFNC), Helmet CPAP, Non Invasive Ventilation (NIV)
- Keywords
- De novo, ARF
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentimaskDevice
The patients will be asked to breathe spontaneously using their actual low oxygen flow
High Flow Nasal cannula (HFNC)Device
The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92%
Helmet CPAPDevice
The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%
Non Invasive Ventilation (NIV)Device
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
| Study group | Role | What they receive |
|---|---|---|
| spontaneous breathing trial | Placebo comparator | the patients will be asked to breathe spontaneously using their actual low oxygen flow Receives: Device: Ventimask; Device: High Flow Nasal cannula (HFNC); Device: Helmet CPAP; Device: Non Invasive Ventilation (NIV) |
| High Flow Nasal cannula (HFNC) | Active comparator | The patients will be asked to breathe with HFNC of 40 L/min Receives: Device: Ventimask; Device: High Flow Nasal cannula (HFNC); Device: Helmet CPAP; Device: Non Invasive Ventilation (NIV) |
| Helmet CPAP | Active comparator | the patients will be asked to breathe with the Helmet CPAP Receives: Device: Ventimask; Device: High Flow Nasal cannula (HFNC); Device: Helmet CPAP; Device: Non Invasive Ventilation (NIV) |
| Non Invasive Ventilation (NIV) | Active comparator | the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface Receives: Device: Ventimask; Device: High Flow Nasal cannula (HFNC); Device: Helmet CPAP; Device: Non Invasive Ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory pattern
the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)
Measured: 30 minutes
respiratory mechanics
the inspiratory effort of the patient recorded by esophageal pressure
Measured: 30 minutes
Secondary outcomes (4)
changes in Arterial Blood Gases (ABGs)
Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery
Measured: immediately after intervention
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 score
this will be assessed using a dedicated visual analog scale (VAS with a length of 20 cm)
Measured: immediately after intervention
Blood pressure (BP) and Heart rate (HR) measurements
blood pressure and heart rate will be assessed
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start20 Jan 2021
- Primary completion31 Mar 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies 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 (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Stefano Nava, MD, Principal investigator, Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ IRCSS S.Orsola-Malpighi University Hospital, Bologna (IT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741659
- Sponsor's protocol ID
- 691/2020/Sper/AOUBo
- Acronym
- DENOVT
- Status last verified
- Nov 2021
- First submitted
- 1 Feb 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure Receiving Non-invasive Respiratory Supports: a Pilot Study
- ClinicalTrials.gov ID
- NCT04741659
- Acronym / sponsor ID
- DENOVT / 691/2020/Sper/AOUBo
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- De novo, ARF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 5 Feb 2021 (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.
Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage in these patients.
The aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| spontaneous breathing trial | Placebo comparator | Device: Ventimask, Device: High Flow Nasal cannula (HFNC), Device: Helmet CPAP, Device: Non Invasive Ventilation (NIV)the patients will be asked to breathe spontaneously using their actual low oxygen flow |
| High Flow Nasal cannula (HFNC) | Active comparator | Device: Ventimask, Device: High Flow Nasal cannula (HFNC), Device: Helmet CPAP, Device: Non Invasive Ventilation (NIV)The patients will be asked to breathe with HFNC of 40 L/min |
| Helmet CPAP | Active comparator | Device: Ventimask, Device: High Flow Nasal cannula (HFNC), Device: Helmet CPAP, Device: Non Invasive Ventilation (NIV)the patients will be asked to breathe with the Helmet CPAP |
| Non Invasive Ventilation (NIV) | Active comparator | Device: Ventimask, Device: High Flow Nasal cannula (HFNC), Device: Helmet CPAP, Device: Non Invasive Ventilation (NIV)the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute Respiratory Failure (ARF) ( 100 <PaO2/FiO2 <300) due to Covid-19 infection
- Informed consent
- Enrollment within the first 24 hours after ARF
Key exclusion criteria (13 listed)
- Clinical, radiological or istological evidence of chronic pulmonary disease.
- Body Mass Index (BMI) > 30 kg/m2;
- Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
- Chest wall disease
- Heart failure
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 |
|---|---|---|
| VentimaskThe patients will be asked to breathe spontaneously using their actual low oxygen flow | Device | Helmet CPAP, High Flow Nasal cannula (HFNC), Non Invasive Ventilation (NIV), spontaneous breathing trial |
| High Flow Nasal cannula (HFNC)The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92% | Device | Helmet CPAP, High Flow Nasal cannula (HFNC), Non Invasive Ventilation (NIV), spontaneous breathing trial |
| Helmet CPAPThe patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92% | Device | Helmet CPAP, High Flow Nasal cannula (HFNC), Non Invasive Ventilation (NIV), spontaneous breathing trial |
| Non Invasive Ventilation (NIV)the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface | Device | Helmet CPAP, High Flow Nasal cannula (HFNC), Non Invasive Ventilation (NIV), spontaneous breathing trial |
Primary outcome
respiratory pattern
Time frame: 30 minutes
the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)
respiratory mechanics
Time frame: 30 minutes
the inspiratory effort of the patient recorded by esophageal pressure
4 secondary outcomes
changes in Arterial Blood Gases (ABGs)
Time frame: immediately after intervention
Dyspnea score
Time frame: immediately after intervention
Comfort score
Time frame: immediately after intervention
Blood pressure (BP) and Heart rate (HR) measurements
Time frame: 30 minutes
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 9 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Stefano Nava, MD principal investigator
Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ IRCSS S.Orsola-Malpighi University Hospital, Bologna (IT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventimask, High Flow Nasal cannula (HFNC) and Helmet CPAP in people with Acute Hypoxemic Respiratory Failure, 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 13 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 9 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
respiratory pattern (time frame: 30 minutes). 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 9 Nov 2021.