Nasal Airflow in Post-operative Patients

March 9, 2026 updated by: Fisher and Paykel Healthcare

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Department of Critical Care Medicine, Auckland City Hospital
        • Principal Investigator:
          • Christopher Hands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TUI-A
Receipt of TUI-1 followed by TUI-2
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
Active Comparator: TUI-B
Receipt of TUI-2 followed by TUI-1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before and 10 minutes after initiation of nasal airflow

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Power spectral density of EEG between interventions
Time Frame: 10 minutes after initiation of nasal airflow
Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands and compared between TUI-1 and TUI-2
10 minutes after initiation of nasal airflow
Coherence
Time Frame: Before and 10 minutes after initiation of nasal airflow
Inter-regional EEG coherence will be quantified as a measure of functional connectivity
Before and 10 minutes after initiation of nasal airflow

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CIA-358

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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