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Nasal High Flow via a Single, Sealed Nostril in Patients with Respiratory Failure

Respiratory Rate in patients with Respiratory Failure in response to Nasal High Flow Therapy delivered via a single sealed nostril

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000831189
Enrollment
28
Registered
2019-06-07
Start date
2019-07-03
Completion date
2021-01-18
Last updated
2021-07-21

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

Conditions

None listed

Brief summary

The study hypothesis is that delivering nasal high flow therapy via a single, sealed nostril will produce similar physiological effects when compared to nasal high flow therapy delivered via a standard interface.

Interventions

The study purpose is to test the delivery of Nasal High Flow (NHF) therapy via a single, sealed nostril in adult patients with respiratory failure who are receiving NHF therapy as their standard care in the intensive care unit (ICU) or high dependency unit (HDU). The therapy will be applied by trained hospital staff. The NHF therapy will be delivered via the single, sealed nostril for up-to one-hour in patients who were already receiving NHF therapy via a two-prong interface (i.e. comparator) a

The study purpose is to test the delivery of Nasal High Flow (NHF) therapy via a single, sealed nostril in adult patients with respiratory failure who are receiving NHF therapy as their standard care in the intensive care unit (ICU) or high dependency unit (HDU). The therapy will be applied by trained hospital staff. The NHF therapy will be delivered via the single, sealed nostril for up-to one-hour in patients who were already receiving NHF therapy via a two-prong interface (i.e. comparator) as their standard care. Before and after using the investigative interface the participant will receive the NHF therapy via the comparator interface. Despite a brief transition time during the exchange of interfaces, there will be no period of time when the patient is not receiving NHF therapy during the study. The primary end-point will be ventilation parameters at ne-hour following the application of the investigative interface for one-hour. The study is a prospective, cross-over design. The study will last for two and a half (2.5) hours. The settings of the NHF while the investigative interface is being applied will be adjusted to match the same patient ventilation parameters as recorded during the use of NHF therapy delivered via the comparator interface. Therefore, the settings of the NHF (flow rate, FiO2) will be adjusted according to each patient. At any time during the study, the patient can request to have the investigative interface removed and replaced by the comparator interface. The patient will be constantly monitored during the study using standard practice and at any time during the study the medical and nursing staff can decide to change therapies if they deem that it is in the best interest of the patient.

Sponsors

Fisher & Paykel Healthcare
Lead SponsorCommercial sector/Industry

Study design

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

Eligibility

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

Inclusion criteria

1. Patient is receiving NHF therapy with Optiflow+ nasal interface 2. Nasal High Flow rate >/= 30 L·min-1 3. FiO2 is between 0.21 and 0.80

Exclusion criteria

1. Less than 18 years’ old 2. Hemodynamic instability 3. Respiratory failure secondary to cardiac failure 4. Neurological or neuromuscular pathologies and/or known phrenic nerve dysfunction 5. Clinician deems patient will not be stable for the duration of the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026