Nasal Airflow in Post-operative Patients
ConditionInvasive Ventilation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFisher and Paykel Healthcare
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults >18 years of age
Receiving sedation via propofol and fentanyl
Undergoing surgical procedure with planned post-operative invasive ventilation
Disqualifiers
Pre-existing neurological injury or condition
Trial design
Design model
Crossover
Treatments tested in this trial
TUI-1
DeviceProvision of airflow to the nasal cavity by F\&P Tui at baseline rate
TUI-2
DeviceProvision of airflow to the nasal cavity by F\&P Tui at modified rate
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: TUI-AActive comparator 2 interventions
Group B: TUI-BActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Power spectral density of EEG
Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands
Time frame
Before and 10 minutes after initiation of nasal airflowSecondary outcomes
1
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
Time frame
10 minutes after initiation of nasal airflow2
Coherence
Inter-regional EEG coherence will be quantified as a measure of functional connectivity
Time frame
Before and 10 minutes after initiation of nasal airflowSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: