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NCT Number: NCT05838326

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

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.

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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Anaesthesia and Intensive Care, Padua University hospital

Padova, 35120, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symmetrical high flow nasal cannula (HFNO)

Device

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)

Device

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.

Primary outcomes

  1. 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)).

  2. 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

  1. Minute ventilation (MV) (L/min)

    Time frame: Last 10 minutes of 1 hour-trial

    To evaluate breathing pattern

  2. corrected MV (L/min)

    Time frame: Last 10 minutes of 1 hour-trial

    To evaluate breathing pattern

  3. Breathing heterogeneity

    Time frame: 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)

  4. Comfort

    Time frame: Last 10 minutes of 1h-trial

    To evaluate changes in comfort, between arms, as assessed by NRS scale

  5. Dyspnea

    Time frame: Last 10 minutes of 1h-trial

    To evaluate changes in dyspnea, between arms, as assessed by VAS scale

  6. Gas exchange

    Time frame: Last 10 minutes of 1h-trial

    To evaluate changes, between arms, in gas exchange (as assessed by PaO2 mmHg, pCO2 mmHg, pH through ABGs)

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study 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.

Acronym: OPTIMARF

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 1, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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