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

NCT05838326 | Completed DMC

• 1 other identifier: AOP2949
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

asymmetrical nasal cannula; hypoxemia; DUET

Outcome Measures

Primary Outcomes (2)

• Breathing effort

  To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).

  Last 10 minutes of 1 hour-trial

• 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 Outcomes (6)

• 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

• Comfort

  Last 10 minutes of 1h-trial

• Dyspnea

  Last 10 minutes of 1h-trial

Study Arms (2)

Symmetrical high flow nasal cannula (HFNO)

ACTIVE COMPARATOR

After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a arterial oxygen pressure (PaO2) and inspiratory oxygen fraction (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 a peripheral saturation (SpO2) between 92 and 98%.

Device: Symmetrical high flow nasal cannula (HFNO)

Asymmetrical high flow nasal cannula (DUET HFNO)

ACTIVE COMPARATOR

After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio \< 300 (as described above), patients will be randomly assigned to a second 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 60L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%.

Device: Asymmetrical high flow nasal cannula (DUET HFNO)

Interventions

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%.

Symmetrical high flow nasal cannula (HFNO)

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.

Asymmetrical high flow nasal cannula (DUET HFNO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• tracheostomy
• non-invasive ventilation after extubation
• second tracheal intubation
• contraindications for EIT belt
• facial or nose abnormalities

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Institute of Anaesthesia and Intensive Care, Padua University hospital

Padua, 35120, Italy

Location

Related Publications (1)

• Boscolo A, Pettenuzzo T, Zarantonello F, Sella N, Pistollato E, De Cassai A, Congedi S, Paiusco I, Bertoldo G, Crociani S, Toma F, Mormando G, Lorenzoni G, Gregori D, Navalesi P. Asymmetrical high-flow nasal cannula performs similarly to standard interface in patients with acute hypoxemic post-extubation respiratory failure: a pilot study. BMC Pulm Med. 2024 Jan 8;24(1):21. doi: 10.1186/s12890-023-02820-x.

  PMID: 38191347 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annalisa Boscolo, MD

  AOUP, DIMED

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 1, 2023
• Study Start: May 8, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

IT (1)