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

Hypoxemia Clinical Trial

— OPTIMARF  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05838326
• Other study ID #: AOP2949
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2023
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

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%.
• 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.

Locations

Country	Name	City	State
Italy	Institute of Anaesthesia and Intensive Care, Padua University hospital	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathing effort	To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).	Last 10 minutes of 1 hour-trial
Primary	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
Secondary	Minute ventilation (MV) (L/min)	To evaluate breathing pattern	Last 10 minutes of 1 hour-trial
Secondary	corrected MV (L/min)	To evaluate breathing pattern	Last 10 minutes of 1 hour-trial
Secondary	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
Secondary	Comfort	To evaluate changes in comfort, between arms, as assessed by NRS scale	Last 10 minutes of 1h-trial
Secondary	Dyspnea	To evaluate changes in dyspnea, between arms, as assessed by VAS scale	Last 10 minutes of 1h-trial
Secondary	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