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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05838326
Other study ID # AOP2949
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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