Acute Respiratory FailureNCT04619641
Physiological Effects of a New Interface on Lung Ventilation and Gas Distribution
A study testing High Flow Nasal Cannula (HFNC) and Continuous Positive Airway Pressure (CPAP) in people with Acute Respiratory Failure, run by University Magna Graecia.
Trial summary
Hypoxemic Acute Respiratory Failure (hARF) is a common reason of admission to Intensive Care. Different modalities can be used to administer oxygen, which is the first supportive treatment in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- High Flow Nasal Cannula (HFNC) and Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of hypoxemic Acute Respiratory Failure
- absence of history of chronic respiratory failure or moderate-to-severe cardiac insufficiency
Who cannot join
- reduced level of consciousness, as indicated by a Glasgow Coma Scale < 12
- severe respiratory distress (i.e. respiratory rate > 35 breaths/min)
- hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion)
- need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min
- life-threatening arrhythmias or electrocardiographic signs of ischemia
- acute respiratory failure secondary to neurological disorders, status asthmaticus, chronic obstructive pulmonary disease (COPD), cardiogenic pulmonary oedema
Show all 13Show fewer
- presence of tracheotomy
- uncontrolled vomiting
- more than 2 acute organ failures
- body mass index >30 kg/m2
- documented history or suspicion of obstructive sleep apnoea
- facial anatomy contraindicating helmet or nasal cannula application
- contraindications to placement of EIT (i.e., pneumothorax, pulmonary emphysema, chest burns or thoracic surgery within 1 week)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Physiological Effects of a New Interface Combining High-flow Nasal Cannula and Cpap on Lung Ventilation and Gas Distribution in Patients With Mild-to-moderate Acute Respiratory Distress Syndrome: a Pilot Study
Hypoxemic Acute Respiratory Failure (hARF) is a common reason of admission to Intensive Care. Different modalities can be used to administer oxygen, which is the first supportive treatment in these patients. Recently a new device combining high flow nasal cannula (HFNC) and continuous positive airway pressure (CPAP) has been developed, but a few is known in these patients.
Investigators have designed this pilot physiologic randomized cross-over study to assess, in patients with hARF, the effects of a new device combining high-flow oxygen through nasal cannula (HFNC) and continuous positive airway pressure (CPAP) on lung aeration and ventilation distribution .
Read the detailed description
Around 30% of patients admitted to the Intensive Care Unit (ICU) are affected by hypoxemic Acute Respiratory Failure (hARF). The primary supportive treatment in hypoxemic patients is oxygen therapy, which is commonly delivered through nasal prongs or masks. New devices, able to deliver high-flow gas through a nasal cannula (HFNC), have been recently made available. HFNC delivers heated and humidified gas up to 60 L/min, with a fraction of inspired oxygen (FiO2) ranging from 0.21 to 1, via a wide bore soft nasal prong. Warming and humidification of the inspired gas prevent the adverse effects of cool dry gases on the airway epithelium and facilitate expectoration. HFNC also washes out exhaled carbon dioxide (CO2) from the pharyngeal dead space. HFNC has been shown an effective means to deliver oxygen therapy in many clinical conditions.
In healthy subject during spontaneous unassisted breathing, end-expiratory pharyngeal pressure is about 0.3 and 0.8 cmH2O, with open and closed mouth, respectively. Compared to unassisted spontaneous breathing, HFNC generates greater pharyngeal pressure during expiration, while in the course of inspiration it drops to zero, which limits the effectiveness of HFNC in patients with lung edema and/or collapse. By recruiting lung atelectatic regions, reducing venous admixture and decreasing the inspiratory effort, continuous positive airway pressure (CPAP) is likely more effective in these instances. Compared to noninvasive ventilation by application of an inspiratory pressure support, CPAP offers several advantages, which include ease of use and lack of patient-ventilator asynchrony.
CPAP may be applied either through mask or helmet. This latter is better tolerated than facial masks and allows more prolonged continuous CPAP application. When applying CPAP by helmet, however, heating and humidification of the inhaled gas is problematic because of condensation of water inside the interface, so called "fog effect". Moreover, in patients receiving CPAP by helmet some re-breathing occurs.
To overcome these limitations and combine the beneficial effects of HFNC and CPAP, investigators designed a new device combining HFNC and helmet CPAP.
Recently, it has been found this combination capable to provide a stable CPAP and effective CO2 washout from the upper airways with negligible CO2 re-breathing. Nonetheless, because of the complex interplay between CPAP and HFNC, the amount of truly applied airway pressure, diaphragm function and temperature inside the helmet might be affected to some extent. In 14 adult healthy volunteers, we found that adding HFNC to CPAP (as referenced to CPAP), 1) did not importantly alter either the pre-set airway pressure during inspiration or temperature inside the helmet; 2) increased expiratory airway pressure proportionally to the flow administered by HFNC, but to a lower extent than HFNC alone (as referenced to spontaneous breathing); 3) determined only slight modifications of the respiratory drive (as assessed through diaphragm ultrasound), compared to CPAP alone, 4) did not cause "fog effect" inside the helmet and 5) did not worsen comfort. We therefore suggested that adding heated humidified air through nasal cannula at a flow of 30 L/min during CPAP would probably be the best setting to be applied in patients with hypoxemic acute respiratory failure.
Electrical Impedance Tomography (EIT) is a non-invasive bedside monitoring device aimed at assessing lung aeration and ventilation. HFNC and CPAP devices was shown to modify lung aeration and ventilation in patients with hARF. However, nothing is known about the effect of the combination of HFNC+CPAP on lung ventilation in patients with hARF. Investigators have therefore designed this pilot physiologic randomized cross-over study to investigate the effects of HFNC+CPAP on lung aeration and ventilation distribution, gas exchange and patient's comfort.
- Conditions
- Acute Respiratory Failure
- Being tested
- High Flow Nasal Cannula (HFNC), Continuous Positive Airway Pressure (CPAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula (HFNC)Device
HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity
Continuous Positive Airway Pressure (CPAP)Device
CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula (HFNC) | Active comparator | HFNC will be applied by means of a dedicated device (AIRVO2, Fisher \& Paykel Healthcare, Auckland, New Zealand). Gas flow will be set at 50 L/min, and humidification chamber will be set at 31°C. Receives: Device: High Flow Nasal Cannula (HFNC) |
| Continuous Positive Airway Pressure (CPAP) | Active comparator | CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
| HFNC+CPAP | Active comparator | HFNC+CPAP consists in the contemporaneous application of HFNC and CPAP through helmet. HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity, while CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet Receives: Device: High Flow Nasal Cannula (HFNC); Device: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of end-expiratory lung impedance (dEELI) from HFNC
change from HFNC, expressed in percentage of the tidal volume, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: After 30 minutes of treatment application
Secondary outcomes (6)
Global Inhomogeneity (GI)
inhomogeneity of air distribution within the lung as assessed through electrical impedance tomography
Measured: After 30 minutes of treatment application
Change of tidal volume in percentage (dVt%) from HFNC
change from HFNC, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Measured: After 30 minutes of treatment application
Arterial partial pressure of oxygen (PaO2)
Analysis of arterial blood gases
Measured: After 30 minutes of treatment application
Arterial partial pressure of carbon dioxide (PaCO2)
Analysis of arterial blood gases
Measured: After 30 minutes of treatment application
Patient's comfort
It will be measured using an 11-point Numeric Rating Scale. Briefly, after detailed explanation before initiating the protocol, patients will be asked to indicate a number between 0 (worst possible comfort) and 10 (no discomfort) on an adapted printed scale.
Measured: After 30 minutes of treatment application
Patient's Dyspnea
It will be measured using an 11-point Numeric Rating Scale. Briefly, after detailed explanation before initiating the protocol, patients will be asked to indicate a number between 0 (no dyspnoea) and 10 (worst possible dyspnoea) on an adapted printed scale.
Measured: After 30 minutes of treatment application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 Acute 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University, Anesthesia and Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619641
- Sponsor's protocol ID
- OptiPAP EIT
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data will be anonymously shared after reasonable request to the Principal Investigator or Corresponding author
Publications
Garofalo E, Bruni A, Pelaia C, Cammarota G, Murabito P, Biamonte E, Abdalla K, Longhini F, Navalesi P. Evaluation of a New Interface Combining High-Flow Nasal Cannula and CPAP. Respir Care. 2019 Oct;64(10):1231-1239. doi: 10.4187/respcare.06871. Epub 2019 Jun 4.
PubMed 31164484Mauri T, Spinelli E, Mariani M, Guzzardella A, Del Prete C, Carlesso E, Tortolani D, Tagliabue P, Pesenti A, Grasselli G. Nasal High Flow Delivered within the Helmet: A New Noninvasive Respiratory Support. Am J Respir Crit Care Med. 2019 Jan 1;199(1):115-117. doi: 10.1164/rccm.201806-1124LE. No abstract available.
PubMed 30240275Grieco DL, Menga LS, Raggi V, Bongiovanni F, Anzellotti GM, Tanzarella ES, Bocci MG, Mercurio G, Dell'Anna AM, Eleuteri D, Bello G, Maviglia R, Conti G, Maggiore SM, Antonelli M. Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. doi: 10.1164/rccm.201904-0841OC.
PubMed 31687831
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of a New Interface Combining High-flow Nasal Cannula and Cpap on Lung Ventilation and Gas Distribution in Patients With Mild-to-moderate Acute Respiratory Distress Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT04619641
- Acronym / sponsor ID
- OptiPAP EIT
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Nov 2020 (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.
Hypoxemic Acute Respiratory Failure (hARF) is a common reason of admission to Intensive Care. Different modalities can be used to administer oxygen, which is the first supportive treatment in these patients. Recently a new device combining high flow nasal cannula (HFNC) and continuous positive airway pressure (CPAP) has been developed, but a few is known in these patients.
Investigators have designed this pilot physiologic randomized cross-over study to assess, in patients with hARF, the effects of a new device combining high-flow oxygen through nasal cannula (HFNC) and continuous positive airway pressure (CPAP) on lung aeration and ventilation distribution .
Detailed description
Around 30% of patients admitted to the Intensive Care Unit (ICU) are affected by hypoxemic Acute Respiratory Failure (hARF). The primary supportive treatment in hypoxemic patients is oxygen therapy, which is commonly delivered through nasal prongs or masks. New devices, able to deliver high-flow gas through a nasal cannula (HFNC), have been recently made available. HFNC delivers heated and humidified gas up to 60 L/min, with a fraction of inspired oxygen (FiO2) ranging from 0.21 to 1, via a wide bore soft nasal prong. Warming and humidification of the inspired gas prevent the adverse effects of cool dry gases on the airway epithelium and facilitate expectoration. HFNC also washes out exhaled carbon dioxide (CO2) from the pharyngeal dead space. HFNC has been shown an effective means to deliver oxygen therapy in many clinical conditions.
In healthy subject during spontaneous unassisted breathing, end-expiratory pharyngeal pressure is about 0.3 and 0.8 cmH2O, with open and closed mouth, respectively. Compared to unassisted spontaneous breathing, HFNC generates greater pharyngeal pressure during expiration, while in the course of inspiration it drops to zero, which limits the effectiveness of HFNC in patients with lung edema and/or collapse. By recruiting lung atelectatic regions, reducing venous admixture and decreasing the inspiratory effort, continuous positive airway pressure (CPAP) is likely more effective in these instances. Compared to noninvasive ventilation by application of an inspiratory pressure support, CPAP offers several advantages, which include ease of use and lack of patient-ventilator asynchrony.
CPAP may be applied either through mask or helmet. This latter is better tolerated than facial masks and allows more prolonged continuous CPAP application. When applying CPAP by helmet, however, heating and humidification of the inhaled gas is problematic because of condensation of water inside the interface, so called "fog effect". Moreover, in patients receiving CPAP by helmet some re-breathing occurs.
To overcome these limitations and combine the beneficial effects of HFNC and CPAP, investigators designed a new device combining HFNC and helmet CPAP.
Recently, it has been found this combination capable to provide a stable CPAP and effective CO2 washout from the upper airways with negligible CO2 re-breathing. Nonetheless, because of the complex interplay between CPAP and HFNC, the amount of truly applied airway pressure, diaphragm function and temperature inside the helmet might be affected to some extent. In 14 adult healthy volunteers, we found that adding HFNC to CPAP (as referenced to CPAP), 1) did not importantly alter either the pre-set airway pressure during inspiration or temperature inside the helmet; 2) increased expiratory airway pressure proportionally to the flow administered by HFNC, but to a lower extent than HFNC alone (as referenced to spontaneous breathing); 3) determined only slight modifications of the respiratory drive (as assessed through diaphragm ultrasound), compared to CPAP alone, 4) did not cause "fog effect" inside the helmet and 5) did not worsen comfort. We therefore suggested that adding heated humidified air through nasal cannula at a flow of 30 L/min during CPAP would probably be the best setting to be applied in patients with hypoxemic acute respiratory failure.
Electrical Impedance Tomography (EIT) is a non-invasive bedside monitoring device aimed at assessing lung aeration and ventilation. HFNC and CPAP devices was shown to modify lung aeration and ventilation in patients with hARF. However, nothing is known about the effect of the combination of HFNC+CPAP on lung ventilation in patients with hARF. Investigators have therefore designed this pilot physiologic randomized cross-over study to investigate the effects of HFNC+CPAP on lung aeration and ventilation distribution, gas exchange and patient's comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula (HFNC) | Active comparator | Device: High Flow Nasal Cannula (HFNC)HFNC will be applied by means of a dedicated device (AIRVO2, Fisher \& Paykel Healthcare, Auckland, New Zealand). Gas flow will be set at 50 L/min, and humidification chamber will be set at 31°C. |
| Continuous Positive Airway Pressure (CPAP) | Active comparator | Device: Continuous Positive Airway Pressure (CPAP)CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet. |
| HFNC+CPAP | Active comparator | Device: High Flow Nasal Cannula (HFNC), Device: Continuous Positive Airway Pressure (CPAP)HFNC+CPAP consists in the contemporaneous application of HFNC and CPAP through helmet. HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity, while CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of hypoxemic Acute Respiratory Failure
- absence of history of chronic respiratory failure or moderate-to-severe cardiac insufficiency
Key exclusion criteria (13 listed)
- reduced level of consciousness, as indicated by a Glasgow Coma Scale < 12
- severe respiratory distress (i.e. respiratory rate > 35 breaths/min)
- hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion)
- need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min
- life-threatening arrhythmias or electrocardiographic signs of ischemia
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 |
|---|---|---|
| High Flow Nasal Cannula (HFNC)HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity | Device | HFNC+CPAP, High flow nasal cannula (HFNC) |
| Continuous Positive Airway Pressure (CPAP)CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet | Device | Continuous Positive Airway Pressure (CPAP), HFNC+CPAP |
Primary outcome
Change of end-expiratory lung impedance (dEELI) from HFNC
Time frame: After 30 minutes of treatment application
change from HFNC, expressed in percentage of the tidal volume, of the end expiratory lung volume as assessed through electrical impedance tomography
6 secondary outcomes
Global Inhomogeneity (GI)
Time frame: After 30 minutes of treatment application
Change of tidal volume in percentage (dVt%) from HFNC
Time frame: After 30 minutes of treatment application
Arterial partial pressure of oxygen (PaO2)
Time frame: After 30 minutes of treatment application
Arterial partial pressure of carbon dioxide (PaCO2)
Time frame: After 30 minutes of treatment application
Patient's comfort
Time frame: After 30 minutes of treatment application
Patient's Dyspnea
Time frame: After 30 minutes of treatment application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Background: PubMed 31164484Garofalo E, Bruni A, Pelaia C, Cammarota G, Murabito P, Biamonte E, Abdalla K, Longhini F, Navalesi P. Evaluation of a New Interface Combining High-Flow Nasal Cannula and CPAP. Respir Care. 2019 Oct;64(10):1231-1239. doi: 10.4187/respcare.06871. Epub 2019 Jun 4.
- Background: PubMed 30240275Mauri T, Spinelli E, Mariani M, Guzzardella A, Del Prete C, Carlesso E, Tortolani D, Tagliabue P, Pesenti A, Grasselli G. Nasal High Flow Delivered within the Helmet: A New Noninvasive Respiratory Support. Am J Respir Crit Care Med. 2019 Jan 1;199(1):115-117. doi: 10.1164/rccm.201806-1124LE. No abstract available.
- Background: PubMed 31687831Grieco DL, Menga LS, Raggi V, Bongiovanni F, Anzellotti GM, Tanzarella ES, Bocci MG, Mercurio G, Dell'Anna AM, Eleuteri D, Bello G, Maviglia R, Conti G, Maggiore SM, Antonelli M. Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. doi: 10.1164/rccm.201904-0841OC.
- Individual participant dataSharing planned: Yes. All individual patient data will be anonymously shared after reasonable request to the Principal Investigator or Corresponding author
Related trials for Acute Respiratory Failure
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Not yet recruitingObservational study
Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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.
Federico Longhini, MD principal investigator
Magna Graecia University, Anesthesia and Intensive Care Unit
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula (HFNC) and Continuous Positive Airway Pressure (CPAP) in people with Acute Respiratory Failure, run by University Magna Graecia.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Nov 2020. 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 Federico Longhini, MD (00393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of end-expiratory lung impedance (dEELI) from HFNC (time frame: After 30 minutes of treatment application). 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 NCT04619641, 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 16 Nov 2020.