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Not yet recruiting NCT07468266

Nasal Airflow in Post-operative Patients

No phase Interventional Invasive Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TUI-1, TUI-2.
Who it may be relevant to
Registry conditions: Invasive Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impacts of F&P Tui on Cortical Activity in Invasively Ventilated Post-operative Patients

Overview

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?

Interventions

  • Device TUI-1
    Provision of airflow to the nasal cavity by F\&P Tui at baseline rate
  • Device TUI-2
    Provision of airflow to the nasal cavity by F\&P Tui at modified rate

Primary outcome measures

  • Power spectral density of EEG [Time frame: Before and 10 minutes after initiation of nasal airflow]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Pre-existing neurological injury or condition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

New Zealand · 1 center
  • Department of Critical Care Medicine, Auckland City Hospital — Auckland

Identifiers

NCT: NCT07468266 · CIA-358

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗