Effects of a New Interface for NIV on Respiratory Drive

NCT04619667 | Unknown

• 1 other identifier: OptiPAP Pes
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Respiratory effort

  Inspiratory effort will be assessed as the negative inspiratory swing of the esophageal pressure

  After 30 minutes of treatment application

Secondary Outcomes (9)

• Dynamic end-expiratory transpulmonary pressure

  After 30 minutes of treatment application

• Dynamic end-inspiratory transpulmonary pressure

  After 30 minutes of treatment application

• Dynamic transpulmonary driving pressure

  After 30 minutes of treatment application

• Diaphragm displacement

  After 30 minutes of treatment application

• Diaphragm thickening fraction

  After 30 minutes of treatment application

Study Arms (3)

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.

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.

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

Device: High Flow Nasal Cannula (HFNC); Device: Continuous Positive Airway Pressure (CPAP)

Interventions

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

HFNC+CPAP; High flow nasal cannula (HFNC)

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

Continuous Positive Airway Pressure (CPAP); HFNC+CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Related Publications (3)

• 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.

  PMID: 31164484 RESULT

• 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.

  PMID: 30240275 RESULT

• 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.

  PMID: 31687831 RESULT

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Federico Longhini, MD

  Magna Graecia University, Anesthesia and Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

00393475395967; longhini.federico@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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