NCT05838326

'Optiflow + Duet' Interface' vs 'Standard' High Flow Nasal Cannula

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Hypoxemia

Interventions

Type	Name	Description
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%.
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.

Timeline

• Start date: 2023-05-08
• Primary completion: 2023-06-30
• Completion: 2023-07-30
• First posted: 2023-05-01
• Last updated: 2023-12-27

Locations

1 site across 1 country: Italy