HFNC vs Two Nare HFNC in Extubated Patients

NCT06398951 | Active Not Recruiting

• 1 other identifier: 87400
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

High flow nasal cannula (HFNC) are introduced to clinical practice to improve oxygenation. Our group were the first to report the use of HFNC in extubated patients that showed comparable delivery of oxygen and improved comfort. These HFNC are subsequently shown to be useful in several clinical conditions in critically ill patients including respiratory failure due to hypoxia, hypercapnia (exacerbation of chronic obstructive lung disease), or post-extubation, pre-intubation oxygenation, and others. Recently a new mode of high flow oxygen therapy has been presented on the market where the prongs of high flow have two different diameters. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. This positive pressure could help in gas exchange of patients who need more oxygen. These devices are approved by the Therapeutic Goods Administration (TGA); the medicine and therapeutic regulatory agency of the Australian Government. Our aim is to compare the two size nare high flow nasal cannula with conventional high flow nasal cannula in extubated patients in intensive care unit in a randomised crossover trial. The comparison will include arterial blood gasses, physiological data including heart rate, respiratory rate, saturations as well as comfort and tolerance of the patients to two size nare high flow nasal cannuale.

Conditions

Oxygen Deficiency

Outcome Measures

Primary Outcomes (3)

• Blood gasses (PaO2 in mmHg)

  To compare if there is difference in PaO2 between two nare and connventional high flow nasal cannula.

  30 minutes each for a total of one hour.

• Blood gasses (PaCO2 in mmHg)

  To compare if there is difference in PaCO2 between two nare and connventional high flow nasal cannula.

  30 minutes each for a total of one hour.

• Blood gasses (SaO2 percentage)

  To compare if there is difference in SaO2 between two nare and connventional high flow nasal cannula.

  30 minutes each for a total of one hour.

Secondary Outcomes (4)

• blood pressure (mmHg)

  30 minutes each for a total of one hour.

• Respiratory rate (breaths per minute)

  30 minutes each for a total of one hour.

• Tolerance as assessed by a 5-point Likert scale ranging from 0-4.

  30 minutes each for a total of one hour.

• Comfort as assessed by a 5-point Likert scale ranging from 1-5.

  30 minutes each for a total of one hour.

Study Arms (2)

Two Nare (Duet) high flow nasal cannula

ACTIVE COMPARATOR

Recently a new mode of high flow oxygen therapy has presented on the market where the cannula of high flow have different diameters. Left cannula larger in diameter than the right. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-60 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient.

Device: Two nare high flow nasal cannula

Conventional High flow nasal cannula

PLACEBO COMPARATOR

Conventional high flow nasal cannula that has been used for many years will be compared with two-nare high flow nasal cannula. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient.

Device: Two nare high flow nasal cannula

Interventions

Two nare high flow nasal cannula DEVICE

Recently a new mode of high flow oxygen therapy has presented on the market where the prongs of high flow have different diameters .These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP.

Conventional High flow nasal cannula; Two Nare (Duet) high flow nasal cannula

Eligibility Criteria

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

You may qualify if:

• All intubated patients imminently requiring extubation with family consent for admittance into the trial that meet the follow criteria:
• P/F ratio between \> 150 prior to extubation
• Has a functional arterial catheter to allow sample of arterial blood gasses.

You may not qualify if:

• Patients being extubated due to withdrawal of therapy Patients being extubated, that are expected to imminently die post extubation P/F Ratio :\< 150 Patients extubated on to non-invasive ventilation Patients with known epistaxis or nasal surgery.

Sponsors & Collaborators

• Peninsula Health: lead

Study Sites (1)

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Related Publications (1)

• Tiruvoipati R, Reddy MP, Paul E, Gupta S, Subramaniam A, Zhang D, Haji K. A comparison of conventional high-flow nasal cannula vs the duet high-flow nasal cannula in extubated patients: a randomized crossover trial. Eur J Med Res. 2025 Mar 26;30(1):205. doi: 10.1186/s40001-025-02447-0.

  PMID: 40140950 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• RAVINDRANATH TIRUVOIPATI, PhD

  Peninsula Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: May 3, 2024
• Study Start: July 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-02

Locations

AU (1)