Physiological Effects of a New Interface on Lung Ventilation and Gas Distribution
NCT ID: NCT04619641
Last Updated: 2020-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2020-12-01
2021-12-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
High Flow Nasal Cannula (HFNC)
HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity
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.
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
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
High Flow Nasal Cannula (HFNC)
HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity
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
Interventions
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High Flow Nasal Cannula (HFNC)
HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity
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
Eligibility Criteria
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Inclusion Criteria
* absence of history of chronic respiratory failure or moderate-to-severe cardiac insufficiency
Exclusion Criteria
* 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
* 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)
* inclusion in other research protocols.
18 Years
ALL
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Federico Longhini
Prof
Principal Investigators
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Federico Longhini, MD
Role: PRINCIPAL_INVESTIGATOR
Magna Graecia University, Anesthesia and Intensive Care Unit
Central Contacts
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References
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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.
Mauri 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.
Grieco 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.
Other Identifiers
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OptiPAP EIT
Identifier Type: -
Identifier Source: org_study_id