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Effects of a New Interface for NIV on Respiratory Drive

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ClinicalTrials.gov Identifier: NCT04619667
Recruitment Status : Not yet recruiting
First Posted : November 6, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Federico Longhini, University Magna Graecia

Brief Summary:
This pilot physiologic randomized cross-over study was designed to investigate if, in patients with hARF, a new device combining high-flow oxygen through nasal cannula (HFNC) and continuous positive airway pressure (CPAP) reduces the respiratory effort, as compared to HFNC and CPAP alone (first outcome). Furthermore, the diaphragm activation, as assessed with ultrasound, gas exchange and patient's comfort among different settings will be assessed (secondary outcomes).

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: High Flow Nasal Cannula (HFNC) Device: Continuous Positive Airway Pressure (CPAP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiological Effects on Respiratory Drive and Transpulmonary Pressure of a New Interface Combining High-flow Nasal Cannula and Cpap in Patients With Mild-to-moderate Acute Respiratory Distress Syndrome: a Pilot Study
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Active Comparator: 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.
Device: High Flow Nasal Cannula (HFNC)
HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity

Active Comparator: 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)
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

Active Comparator: 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
Device: 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: 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




Primary Outcome Measures :
  1. Respiratory effort [ Time Frame: After 30 minutes of treatment application ]
    Inspiratory effort will be assessed as the negative inspiratory swing of the esophageal pressure


Secondary Outcome Measures :
  1. Dynamic end-expiratory transpulmonary pressure [ Time Frame: After 30 minutes of treatment application ]
    Difference between airway pressure and end-expiratory esophageal pressure

  2. Dynamic end-inspiratory transpulmonary pressure [ Time Frame: After 30 minutes of treatment application ]
    Difference between airway pressure and end-inspiratory esophageal pressure

  3. Dynamic transpulmonary driving pressure [ Time Frame: After 30 minutes of treatment application ]
    Maximal positive swing in transpulmonary pressure during inspiration

  4. Diaphragm displacement [ Time Frame: After 30 minutes of treatment application ]
    Diaphragm displacement will be assessed with ultrasound to display the cranio-caudal motion of the diaphragm

  5. Diaphragm thickening fraction [ Time Frame: After 30 minutes of treatment application ]
    Thickening fraction will be determined with ultrasound in M-mode at end-expiration (Thickexp) and peak inspiration (Thickinsp) as the distance between the diaphragmatic pleura and the peritoneum

  6. Arterial partial pressure of oxygen (PaO2) [ Time Frame: After 30 minutes of treatment application ]
    Analysis of arterial blood gases

  7. Arterial partial pressure of carbon dioxide (PaCO2) [ Time Frame: After 30 minutes of treatment application ]
    Analysis of arterial blood gases

  8. Patient's comfort [ Time Frame: After 30 minutes of treatment application ]
    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.

  9. Patient's Dyspnea [ Time Frame: After 30 minutes of treatment application ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of hypoxemic Acute Respiratory Failure, as defined by a respiratory rate greater than 25 breaths/min, an acute onset (within 1 week) of respiratory distress, an arterial oxygen tension (PaO2) and inspiratory oxygen fraction (FiO2) ratio (PaO2/FiO2) lower than 200 mmHg during HFNC, an evidence of bilateral pulmonary infiltrates in the chest X-ray or computed tomography scan, and an absence of history of chronic respiratory failure or moderate-to-severe cardiac insufficiency (New York Heart Association greater than grade 2 or left ventricular ejection fraction <50%).

Exclusion Criteria:

  • 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
  • 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
  • contraindications to placement of a nasal-gastric feeding tube
  • facial anatomy contraindicating helmet or nasal cannula application
  • inclusion in other research protocols.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619667


Contacts
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Contact: Federico Longhini, MD 00393475395967 longhini.federico@gmail.com

Sponsors and Collaborators
University Magna Graecia
Investigators
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Principal Investigator: Federico Longhini, MD Magna Graecia University, Anesthesia and Intensive Care Unit
Publications of Results:
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Responsible Party: Federico Longhini, Prof, University Magna Graecia
ClinicalTrials.gov Identifier: NCT04619667    
Other Study ID Numbers: OptiPAP Pes
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual patient data will be anonymously shared after reasonable request to the Principal Investigator or Corresponding author
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After study and results publication on an international medical journal
Access Criteria: On reasonable request to the corresponding author or principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases