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

Not Applicable

Completed

• Conditions: Hypoxemia

• 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

Primary Outcome Measures

Name	Time	Method
Breathing effort	Last 10 minutes of 1 hour-trial	To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).
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.

Secondary Outcome Measures

Name	Time	Method
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
Comfort	Last 10 minutes of 1h-trial	To evaluate changes in comfort, between arms, as assessed by NRS 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