An interventional study of NAVA vs PSV - TCCD in Neuro: Cerebrovascular Accident and Trauma, Head, sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita · Not applicable, Interventional, and Treatment
Partial assisted mechanical ventilation modes are widely used to manage respiratory failure. It has been demonstrated that they can reduce complications related to mechanical ventilation and neuromuscular blocking agents administration.
During partially assisted ventilation, there is no predefined respiratory rate and the patient must trigger each breath.
One of the most used partial assisted mode is pressure support ventilation (PSV), which plays a key role in weaning from mechanical ventilation, especially in neuro-cranial diseases.
Neurally adjusted ventilatory assist mode (NAVA) has been introduced in clinical practice in recent years. It has been widely demonstrated that NAVA is able to guarantee gas exchange in the same way as PSV in patients admitted to ICU for respiratory failure.
Thus, NAVA can improve patient-ventilator interaction reducing the incidence of asynchronous events and favoring the patient's own ventilatory pattern. Nevertheless, NAVA does not appear to have been applied in neuro ICU patients. In a study conducted on non-neurosurgical infants has been demonstrated negative effects of asynchronous events on cerebral blood flow velocities, examined with transcranial Doppler technique.
In the present pilot study, the investigators would like to compare NAVA and PSV ventilation influence on cranial blood flow, evaluated with Trans-Cranial Color Doppler, in patients admitted to ICU for neurological injuries.
The aim of this pilot study is to compare NAVA and PSV in order to establish their influence on cranial blood flow, assessed in the mean cerebral artery (M1 tract bilaterally). Secondarily, it will be evaluated the effectiveness in guaranteeing the gas exchange and patient-ventilator interaction during each ventilation mode.
Patients will be evaluated in order to establish their readiness for assisted mechanical ventilation.
The following clinical criteria must be respected:
The expiratory trigger will be adjusted to the 50% of the inspiratory flow peak in PSV. During NAVA, the expiratory trigger is fixed to 75% of diaphragmatic electrical activity. The inspiratory fraction of oxygen (FiO2) will be set in order to obtain a peripheral oxygen saturation of more than 94%.
Ultrasound evaluation, using transcranial Doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle length and at the bifurcation of M1 bilaterally, at the end of every ventilation trial. At the end of each trial, PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs. Moreover, traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker.
This will allow evaluating the patient-ventilator interaction (trigger delay, asynchronous events, and asynchrony index).
263 studies on the registry are indexed under Craniocerebral Trauma; 44 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 141 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Azienda Ospedaliero Universitaria Maggiore della Carita is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Ultrasound evaluation, using trans cranial doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally, at the end of every ventilation trial (NAVA and PSV).
Other: NAVA vs PSV - TCCD
Patients will be submitted to 3 different 30 minutes ventilation trials: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. PSV will have PEEP setted by clinician and pressure support set in order to obtain Vt 6-8 ml/kg. NAVA will have the same PEEP as PSV and NAVA level will be set to obtain the same Peak of Inspiratory Pressure) of PSV. Trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) at the end of every ventilation trial. At the end of each trial, ABGs will be performed. Traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker.
NAVA safety- Change in cranial blood flow velocity
Ultrasound evaluation, using trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally.
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess cerebral blood flow. This evaluation will be performed over time range of 5-15 seconds (in any case the time of 3 doppler signal beats)
Gas exchange - arterial carbon dioxide tension
PaCO2, will be obtained performing ABG sample
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.
Gas exchange - pH
pH will be obtained performing ABGs.
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of
Gas exchange - arterial oxygen tension
arterial oxygenation PaO2 will be obtained performing ABGs.
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.
Patient-ventilator interaction 1
trigger delay (msec)
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Patient-ventilator interaction 2
synchronous events (total number of asynchrony events) and asynchrony index.
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Patient-ventilator interaction 3
asynchrony index (total number of asynchrony events on respiratory rate \*100)
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Plan to share: Undecided
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliero Universitaria Maggiore della Carita