Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute Respiratory Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | March 28, 2014 |
| End Date: | June 1, 2019 |
| Contact: | Robert M Kacmarek, PhD, RRT |
| Email: | rkacmarek@partners.org |
| Phone: | 617-724 4480 |
A Comparative, Multicenter, Randomized, Controlled Study of Neurally Adjusted Ventilatory Assist (NAVA) vs. Conventional Lung Protective Ventilation in Patients With Acute Respiratory Failure
The purpose of this study is to compare a specific mode of artificial ventilation (help from
a breathing machine) with other modes. This specific mode is called Neurally Adjusted
Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from
the diaphragm (breathing muscle) to help patients breathe. The investigators believe that
using these signals, NAVA can determine the exact timing for patients' spontaneous breathing
effort and delivers the artificial breath at the same time (in synchrony) with their own
breath. Other modes (breathing methods) may cause asynchrony between the patient and the
ventilator while delivering artificial breaths because of the way they operate. Asyncrony
between patient and ventilator is a risk factor for increasing the length of artificial
ventilation and number of related complications. The investigators would like to find out if
NAVA performs better in establishing synchrony between patient and ventilator and as a result
decreasing time for artificial ventilation and increasing better outcomes.
a breathing machine) with other modes. This specific mode is called Neurally Adjusted
Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from
the diaphragm (breathing muscle) to help patients breathe. The investigators believe that
using these signals, NAVA can determine the exact timing for patients' spontaneous breathing
effort and delivers the artificial breath at the same time (in synchrony) with their own
breath. Other modes (breathing methods) may cause asynchrony between the patient and the
ventilator while delivering artificial breaths because of the way they operate. Asyncrony
between patient and ventilator is a risk factor for increasing the length of artificial
ventilation and number of related complications. The investigators would like to find out if
NAVA performs better in establishing synchrony between patient and ventilator and as a result
decreasing time for artificial ventilation and increasing better outcomes.
Study Goal To compare the ability of NAVA vs. conventional lung protective ventilation in a
multicenter, unblinded, randomized, controlled fashion to provide invasive ventilatory
support during acute respiratory failure in adults with an AI >5% who are expected to require
ventilatory support for greater than 72 hours.
Hypothesis It is hypothesized that the use of NAVA compared to conventional lung protective
ventilation will result in a decrease in the number of days of mechanical ventilation. It is
further hypothesized that NAVA compared to conventional lung protective ventilation will
result in a decrease in the length of weaning, the length of ICU and hospital stay, and
mortality.
Primary Outcome
• Number of invasive ventilator free days.
Secondary Outcome
- Total mechanical ventilation (invasive plus noninvasive) free days
- Mortality
- Length of Invasive Ventilation
- Length of post extubation NIV
- Total length of mechanical ventilation (invasive plus noninvasive)
- Length of ICU and hospital stay
- Development of extrapulmonary organ failure (any organ failure developed during the
study that was not present at the time of enrollment into the study)
- Incidence of barotrauma (defined as the presence of any extra-pulmonary air that was not
present at study enrollment).
- Ventilator associated pneumonia (development of a pneumonia 48 hrs after entry into the
study).
- Development of ARDS (after enrollment into the study; defined as a rapid onset, a
P/F<200 mmHg, and bilateral pulmonary infiltrates that are not of cardiac origin).
multicenter, unblinded, randomized, controlled fashion to provide invasive ventilatory
support during acute respiratory failure in adults with an AI >5% who are expected to require
ventilatory support for greater than 72 hours.
Hypothesis It is hypothesized that the use of NAVA compared to conventional lung protective
ventilation will result in a decrease in the number of days of mechanical ventilation. It is
further hypothesized that NAVA compared to conventional lung protective ventilation will
result in a decrease in the length of weaning, the length of ICU and hospital stay, and
mortality.
Primary Outcome
• Number of invasive ventilator free days.
Secondary Outcome
- Total mechanical ventilation (invasive plus noninvasive) free days
- Mortality
- Length of Invasive Ventilation
- Length of post extubation NIV
- Total length of mechanical ventilation (invasive plus noninvasive)
- Length of ICU and hospital stay
- Development of extrapulmonary organ failure (any organ failure developed during the
study that was not present at the time of enrollment into the study)
- Incidence of barotrauma (defined as the presence of any extra-pulmonary air that was not
present at study enrollment).
- Ventilator associated pneumonia (development of a pneumonia 48 hrs after entry into the
study).
- Development of ARDS (after enrollment into the study; defined as a rapid onset, a
P/F<200 mmHg, and bilateral pulmonary infiltrates that are not of cardiac origin).
Inclusion Criteria:
- Age greater than or equal to 18 years
- Hypoxemic or hypercapnic acute respiratory failure
- Intubation and mechanical ventilation
- Anticipated mechanical ventilation longer than 72 hrs
- Mechanically ventilated < 48 hours
- Able to spontaneously trigger the ventilator
Exclusion Criteria:
- Acute respiratory distress syndrome
- Post-operative patient's normally requiring a short course of mechanical ventilation
(for example most cardiac surgical patients)
- Equal to or greater than 3 total organ failures
- Unable to spontaneously breathe
- Need to provide controlled ventilation
- Poor short term prognosis (defined as a high risk of death in the next 3 months)
- Neuromuscular or neurologic disease
- Age < 18 years
- Weight < 35 kg predicted body weight (PBW).
- Patients with major esophageal, gastric and oral surgery
- Body mass index > 50
- Acute brain injury or elevated intracranial pressure (> 18 mmHg)
- Immunosuppressed patients receiving chemotherapy or radiation therapy (less than 2
month after chemotherapy or radiation therapy).
- Severe cardiac disease: New York Heart Association class 3 or 4 or acute coronary
syndrome or persistent ventricular tachyarrhythmias.
- Pregnancy, must be confirmed by laboratory analysis.
- Sickle cell disease
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