'Optiflow + Duet' Interface' vs 'Standard' High Flow Nasal Cannula (OPTIMARF)

Physiological Effects of High Flow Oxygen Therapy Using 'Optiflow + Duet' Interface vs 'Standard' High Flow Nasal Cannula for Acute Respiratory Failure After Extubation. The OPTIMARF Study.

High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Promising data have been published in vitro about new asymmetrical high flow nasal cannula, named 'Optiflow + DUET'. Positive airway pressure, that dynamically changes with breathing, and clearance of anatomical dead space are the key mechanisms of noninvasive respiratory support with nasal high flow. Pressure mainly depends on flow rate and nare occlusion. The hypothesis is that an increase in asymmetrical occlusion of the nares leads to an improvement in dead-space clearance resulting in a reduction in re-breathing and breathing work.

Study Overview

• Status: Completed
• Conditions: Hypoxemia
• Intervention / Treatment: Device: Symmetrical high flow nasal cannula (HFNO); Device: Asymmetrical high flow nasal cannula (DUET HFNO)

Detailed Description

A prospective cross-over RCT on the effects of 'Optiflow + DUET' as compared to convetional symmetrical high flow cannula and Venturi mask.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35120
    • Institute of Anaesthesia and Intensive Care, Padua University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age >18 years old;
• invasive mechanical ventilation > 24h;
• acute respiratory failure within 120 minutes after extubation (defined during a spontaneous trial using Venturi mask and assessing a PaO2/FiO2 ratio < 300;
• absence of Sars-Cov-2 positivity;
• absence of cardiological or long-term respiratory disease

Exclusion Criteria:

• pregnancy
• tracheostomy
• non-invasive ventilation after extubation
• second tracheal intubation
• contraindications for EIT belt
• facial or nose abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Symmetrical high flow nasal cannula (HFNO); After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a arterial oxygen pressure (PaO2) and inspiratory oxygen fraction (FiO2) ratio < 300, patients will be randomly assigned to a first 1h-phase of 'conventional HFNO' or 'DUET HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain a peripheral saturation (SpO2) between 92 and 98%.	Device: Symmetrical high flow nasal cannula (HFNO); After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300, patients will be randomly assigned to a first 1h-phase of 'conventional HFNO' or 'DUET HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%.
Active Comparator: Asymmetrical high flow nasal cannula (DUET HFNO); After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300 (as described above), patients will be randomly assigned to a second 1h-phase of 'DUET HFNO' vs 'conventional HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%.	Device: Asymmetrical high flow nasal cannula (DUET HFNO); After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300, patients will be randomly assigned to a first 1h-phase of 'DUET HFNO' vs 'conventional HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%. A 5-10min 'washout' phase using VM, between different interfaces, will be allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung aeration	To evaluate changes, between arms, in lung aeration (as assessed by the end-expiratory lung impedance (delta EELI) through EIT.	Last 10 minutes of 1 hour-trial
Breathing effort	To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).	Last 10 minutes of 1 hour-trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing heterogeneity	To evaluate changes, between arms, in ventilation distribution (as assessed by pendelluft (yes/not), respiratory rates/min, tidal volume (ml), global inhomogeneity index through EIT)	Last 10 minutes of 1 hour-trial
Comfort	To evaluate changes in comfort, between arms, as assessed by NRS scale	Last 10 minutes of 1h-trial
Dyspnea	To evaluate changes in dyspnea, between arms, as assessed by VAS scale	Last 10 minutes of 1h-trial
Gas exchange	To evaluate changes, between arms, in gas exchange (as assessed by PaO2 mmHg, pCO2 mmHg, pH through ABGs)	Last 10 minutes of 1h-trial
Minute ventilation (MV) (L/min)	To evaluate breathing pattern	Last 10 minutes of 1 hour-trial
corrected MV (L/min)	To evaluate breathing pattern	Last 10 minutes of 1 hour-trial

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Annalisa Boscolo, MD, AOUP, DIMED

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: hypoxemia; asymmetrical nasal cannula; DUET
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: AOP2949

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No