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

Not Applicable

Completed

• Conditions: Hypoxemia
• Interventions: Device: Symmetrical high flow nasal cannula (HFNO); Device: Asymmetrical high flow nasal cannula (DUET HFNO)

• Registration Number: NCT05838326
• Lead Sponsor: University of Padova

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-01
• Study Start: 2023-05-08
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Symmetrical high flow nasal cannula (HFNO)	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%.
Asymmetrical high flow nasal cannula (DUET HFNO)	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%.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comfort	Last 10 minutes of 1h-trial	To evaluate changes in comfort, between arms, as assessed by NRS scale
Minute ventilation (MV) (L/min)	Last 10 minutes of 1 hour-trial	To evaluate breathing pattern
corrected MV (L/min)	Last 10 minutes of 1 hour-trial	To evaluate breathing pattern
Breathing heterogeneity	Last 10 minutes of 1 hour-trial	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)
Dyspnea	Last 10 minutes of 1h-trial	To evaluate changes in dyspnea, between arms, as assessed by VAS scale
Gas exchange	Last 10 minutes of 1h-trial	To evaluate changes, between arms, in gas exchange (as assessed by PaO2 mmHg, pCO2 mmHg, pH through ABGs)

Trial Locations

Locations (1)

Institute of Anaesthesia and Intensive Care, Padua University hospital; 🇮🇹 Padova, Italy