Comparison Between NAVA and PSV in Neurocritical Patients

Comparison Between NAVA and PSV in Neurocritical Patients: a Pilot Study

Sponsors

Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Source Azienda Ospedaliero Universitaria Maggiore della Carita
Brief Summary

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.

Detailed Description

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:

- a heart rate of less than 120 bpm, blood pressure between 90 and 180 mmHg;

- dopamine/dobutamine less than 5 mcg/kg/minute, norepinephrine less than 0.25 mcg/kg/min;

- PaO2/FiO2 > 150;

- PEEP (positive end-expiratory pressure) minor or equal to 10 cmH2O;

- Vt between 6 and 8 ml/kg;

- respiratory rate less than 35 breaths per minutes and without respiratory distress signs;

- blood pH between 7.35 and 7.45; Afterward, patients will be submitted to three different mechanical ventilation trials in partially assisted modes: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. Each trial will last 30 minutes. PSV will have PEEP set by clinician and pressure support will be set in order to obtain Vt between 6 and 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.

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).

Overall Status Recruiting
Start Date November 1, 2018
Completion Date December 31, 2019
Primary Completion Date December 31, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
NAVA safety- Change in cranial blood flow velocity 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)
Secondary Outcome
Measure Time Frame
Gas exchange - arterial carbon dioxide tension 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 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 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 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 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 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.
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: NAVA vs PSV - TCCD

Description: 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.

Arm Group Label: NAVA vs PSV -TCCD

Eligibility

Criteria:

Inclusion Criteria:

- Every ICU patient sedated and intubated, admitted for intracranial disease (neuromuscular disease and head trauma);

- intracranial pressure monitoring

- Mechanical ventilation for more than 48 hours

- Readiness for assisted mechanical ventilation at the screening

Exclusion Criteria:

- intracranial pressure instability more than 15 cmH2O;

- symptomatic vasospasm;

- average cerebral flow velocity at transcranial basal doppler in M1 more than 120 cm/sec

- hemodynamic instability;

- gastro-esophageal surgery in the previous 12 months;

- gastro-esophageal bleeding in the previous 30 days;

- history of esophageal varices;

- maxillofacial trauma or surgery;

- body temperature more than 38° C at the time of the study;

- coagulation disorders;

- PaCO2 not included in the basal range (between 35 and 45 mmHg) or paCo2 variation more than +/- 20% obtained in partially assisted mode compared to baseline;

- pregnancy;

- inclusion in other research projects;

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gianmaria Cammarota, MD,PHD Principal Investigator "Maggiore della Carità" Hospital
Overall Contact

Last Name: Gianmaria Cammarota, MD, PhD

Phone: 00393392669420

Email: [email protected]

Location
Facility: Status: Contact: A.O.U Maggiore della Carità Gianmaria Cammarota, MD,PhD 003903213733406 [email protected]
Location Countries

Italy

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita

Investigator Full Name: Gianmaria Cammarota

Investigator Title: Principal investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: NAVA vs PSV -TCCD

Type: Experimental

Description: 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).

Acronym NAVAPSVHEAD
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: pilot interventional study

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: the ultrasonography examiner is blind on the ventilatory mode

Source: ClinicalTrials.gov