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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxemia
- Sponsor
- University of Padova
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Breathing effort
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Breathing effort
Time Frame: Last 10 minutes of 1 hour-trial
To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).
Lung aeration
Time Frame: 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 Outcomes
- Minute ventilation (MV) (L/min)(Last 10 minutes of 1 hour-trial)
- corrected MV (L/min)(Last 10 minutes of 1 hour-trial)
- Breathing heterogeneity(Last 10 minutes of 1 hour-trial)
- Dyspnea(Last 10 minutes of 1h-trial)
- Comfort(Last 10 minutes of 1h-trial)
- Gas exchange(Last 10 minutes of 1h-trial)