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Novel nasal high flow interface feasibility in the acute setting

Comfort, Tolerability and Usability of a novel nasal high flow interface in the ICU and HDU

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001360404
Enrollment
15
Registered
2025-12-05
Start date
2027-03-23
Completion date
2027-09-21
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients who are admitted to the intensive care unit or high dependency unit with respiratory compromise are likely to experience stress and discomfort, so it is important to develop new ways to improve patient comfort and streamline the process of initiating their respiratory support. Fisher & Paykel Healthcare is sponsoring a single-centre, pilot, feasibility study to assess the feasibility, comfort, and tolerability of a novel nasal high flow cannula. This study aims to recruit at least 15 patients who are prescribed to use nasal high flow therapy within the ICU/HDU for no less than 8 hours, and up to 7 days. Observations from healthcare professions, patient comments, and an extensive questionnaire will help to determine whether this new cannula's design is feasible for both patients and healthcare professionals.

Interventions

The intervention is a new nasal high flow cannula for acutely-ill patients in intensive care unit (ICU) or high dependency unit (HDU). This nasal cannula is fitted to the patient in the same way as a standard Optiflow nasal cannula. Key changes to the novel cannula include: - A flexible hinge on the interface frame to maintain a comfortable placement on the patient face (as opposed to a fixed, continuous frame) - The manifold has the ability to rotate 360 degrees to swap the flexi-tube side.

The intervention is a new nasal high flow cannula for acutely-ill patients in intensive care unit (ICU) or high dependency unit (HDU). This nasal cannula is fitted to the patient in the same way as a standard Optiflow nasal cannula. Key changes to the novel cannula include: - A flexible hinge on the interface frame to maintain a comfortable placement on the patient face (as opposed to a fixed, continuous frame) - The manifold has the ability to rotate 360 degrees to swap the flexi-tube side. Current interfaces either are unable to swap sides or require disassembly and reassembly. - Introduction of modular prongs which can be removed from the interface and easily swap sizes. Current interfaces are a fixed size and require a full new interface to change sizes. The novel nasal cannula still provides nasal high flow therapy in the same way as prior cannula, and can deliver flows from 5-70 L/min. Eligible participants who are prescribed nasal high flow will be fitted with the new nasal cannula by a healthcare professional through which they will receive nasal high flow with room air, and oxygen if required, at their prescribed settings (same settings as for their standard care). Participants will be receiving this therapy for a minimum of 8 hours, up to a maximum of 7 days depending on their nasal high flow prescription. Participants will be asked to rate their level of comfort and tolerance every 12 hours, to determine adherence and comfort, and healthcare professionals will be asked to provide observations and rate the usability process.

Sponsors

Fisher & Paykel Healthcare
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

IC #1 Adult patients (age 18+). IC #2 Patients admitted to ICU and HDU IC #3 Patients with a prescription for NHF IC #4 Fit cognitive state with the ability to provide informed consent.

Exclusion criteria

EC #1 Off-label use (e.g. non-spontaneously breathing patients) EC #2 Presence of any comorbidities that may affect the patient’s condition significantly within the next 8 hours, as assessed by the investigator

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 17, 2026