Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute Respiratory Failure
|Acute Respiratory Failure||Other: NAVA ventilation Other: Conventional Lung Protective Ventilation|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparative, Multicenter, Randomized, Controlled Study of Neurally Adjusted Ventilatory Assist (NAVA) vs. Conventional Lung Protective Ventilation in Patients With Acute Respiratory Failure|
- Number of invasive ventilator free days. [ Time Frame: 90 Days ]
- Total length of mechanical ventilation (invasive plus noninvasive) [ Time Frame: 90 Days ]
- Length of ICU stay [ Time Frame: 90 Days ]
- Length of hospital stay [ Time Frame: 90 Days ]
- Mortality [ Time Frame: 90 Days ]
- Ventilator associated pneumonia [ Time Frame: 90 Days ]
- Incidence of barotrauma [ Time Frame: 90 Days ]
- Development of Acute respiratory distress syndrome (ARDS) [ Time Frame: 90 Days ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Conventional Lung Protective Ventilation
In this group, patients will be ventilated in either volume A/C, pressure A/C, pressure support, pressure regulated volume control or volume support based on the discretion of the medical team with TV 4-8 ml/kg PBW range and PP or pressure (control or support) level <30 cmH2O.
Other: Conventional Lung Protective Ventilation
conventional protective mechanical ventilation
NAVA Ventilation Group
In the NAVA group, NAVA level will be set initially at zero, then the maximum Edi will be determined as the average level over the next 3 to 5 breaths without ventilatory support or PEEP. The actual NAVA level will then be titrated by the clinician to achieve the following: 1) an Edi equal to approximately 50% of the maximum Edi, 2) an average tidal volume of between 4 to 8 ml/kg predicted body weight (PBW), and 3) an average respiratory rate between about 15 and 40 per minute. In addition, the trigger sensitivity should be set as sensitive as possible without causing auto-triggering and the maximum pressure limit in NAVA should be set at 40 cm H2O.
Other: NAVA ventilation
Neurally adjusted ventilatory assist
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.
• Number of invasive ventilator free days.
- Total mechanical ventilation (invasive plus noninvasive) free days
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730794
|Contact: Robert M Kacmarek, PhD, RRT||617-724 email@example.com|
|Contact: Demet S Sulemanji, MD||617-724 firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Withdrawn|
|Boston, Massachusetts, United States, 02114|
|Hospital Clinico de Valencia||Recruiting|
|Contact: Javier Belda, MD, PhD email@example.com|
|Contact: Carlos Ferrando, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Robert M Kacmarek, PhD||Massachusetts General Hospital|
|Principal Investigator:||Jesus Villar, MD, PhD||H. Dr. Negrín, Las Palmas de Gran Canaria|