Invasive VentilationNCT07468266
Nasal Airflow in Post-operative Patients
A study testing TUI-1 and TUI-2 in people with Invasive Ventilation, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
The goal of this investigation is to examine the effect of nasal airflow in invasively ventilated adult patients following planned surgery. The main questions it aims to answer are: Does the investigational device produce an effect measured by EEG? Are there differences in effect with modified airflow states? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Ventilation
- What is being tested?
- TUI-1 and TUI-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNew Zealand
- Study dates
- Mar 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years of age
- Receiving sedation via propofol and fentanyl
- Undergoing surgical procedure with planned post-operative invasive ventilation
Who cannot join
- Pre-existing neurological injury or condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site
Department of Critical Care Medicine, Auckland City Hospital
Auckland
Christopher Hands
About this study
Official title: Impacts of F&P Tui on Cortical Activity in Invasively Ventilated Post-operative Patients
The goal of this investigation is to examine the effect of nasal airflow in invasively ventilated adult patients following planned surgery. The main questions it aims to answer are:
- Does the investigational device produce an effect measured by EEG?
- Are there differences in effect with modified airflow states?
- Conditions
- Invasive Ventilation
- Being tested
- TUI-1, TUI-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUI-1Device
Provision of airflow to the nasal cavity by F\&P Tui at baseline rate
TUI-2Device
Provision of airflow to the nasal cavity by F\&P Tui at modified rate
| Study group | Role | What they receive |
|---|---|---|
| TUI-A | Active comparator | Receipt of TUI-1 followed by TUI-2 Receives: Device: TUI-1; Device: TUI-2 |
| TUI-B | Active comparator | Receipt of TUI-2 followed by TUI-1 Receives: Device: TUI-1; Device: TUI-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power spectral density of EEG
Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands
Measured: Before and 10 minutes after initiation of nasal airflow
Secondary outcomes (2)
Power spectral density of EEG between interventions
Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands and compared between TUI-1 and TUI-2
Measured: 10 minutes after initiation of nasal airflow
Coherence
Inter-regional EEG coherence will be quantified as a measure of functional connectivity
Measured: Before and 10 minutes after initiation of nasal airflow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive VentilationStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468266
- Sponsor's protocol ID
- CIA-358
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of F&P Tui on Cortical Activity in Invasively Ventilated Post-operative Patients
- ClinicalTrials.gov ID
- NCT07468266
- Acronym / sponsor ID
- CIA-358
- Conditions
- Invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this investigation is to examine the effect of nasal airflow in invasively ventilated adult patients following planned surgery. The main questions it aims to answer are:
- Does the investigational device produce an effect measured by EEG?
- Are there differences in effect with modified airflow states?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUI-A | Active comparator | Device: TUI-1, Device: TUI-2Receipt of TUI-1 followed by TUI-2 |
| TUI-B | Active comparator | Device: TUI-1, Device: TUI-2Receipt of TUI-2 followed by TUI-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults >18 years of age
- Receiving sedation via propofol and fentanyl
- Undergoing surgical procedure with planned post-operative invasive ventilation
Key exclusion criteria (1 listed)
- Pre-existing neurological injury or condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUI-1Provision of airflow to the nasal cavity by F\&P Tui at baseline rate | Device | TUI-A, TUI-B |
| TUI-2Provision of airflow to the nasal cavity by F\&P Tui at modified rate | Device | TUI-A, TUI-B |
Primary outcome
Power spectral density of EEG
Time frame: Before and 10 minutes after initiation of nasal airflow
Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands
2 secondary outcomes
Power spectral density of EEG between interventions
Time frame: 10 minutes after initiation of nasal airflow
Coherence
Time frame: Before and 10 minutes after initiation of nasal airflow
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TUI-1 and TUI-2 in people with Invasive Ventilation, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Gradon (09 574 0100, kelly.gradon@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power spectral density of EEG (time frame: Before and 10 minutes after initiation of nasal airflow). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.