NCT07468266

Brief 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?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Feb 2027

Study Start

First participant enrolled

March 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 3, 2026

Last Update Submit

March 9, 2026

Conditions

Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • Power spectral density of EEG

    Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands

    Before and 10 minutes after initiation of nasal airflow

Secondary Outcomes (2)

  • Power spectral density of EEG between interventions

    10 minutes after initiation of nasal airflow

  • Coherence

    Before and 10 minutes after initiation of nasal airflow

Study Arms (2)

TUI-A

ACTIVE COMPARATOR

Receipt of TUI-1 followed by TUI-2

Device: TUI-1Device: TUI-2

TUI-B

ACTIVE COMPARATOR

Receipt of TUI-2 followed by TUI-1

Device: TUI-1Device: TUI-2

Interventions

TUI-1DEVICE

Provision of airflow to the nasal cavity by F\&P Tui at baseline rate

TUI-ATUI-B
TUI-2DEVICE

Provision of airflow to the nasal cavity by F\&P Tui at modified rate

TUI-ATUI-B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \>18 years of age
  • Receiving sedation via propofol and fentanyl
  • Undergoing surgical procedure with planned post-operative invasive ventilation

You may not qualify if:

  • Pre-existing neurological injury or condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Auckland City Hospital

Auckland, New Zealand

Location

Central Study Contacts

Kelly Gradon

CONTACT

09 574 0100kelly.gradon@fphcare.co.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 12, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

NZ(1)