Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults 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.
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 ] [ Designated as safety issue: No ]
- Total length of mechanical ventilation (invasive plus noninvasive) [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- Length of ICU stay [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- Ventilator associated pneumonia [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- Incidence of barotrauma [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- Development of Acute respiratory distress syndrome (ARDS) [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2014|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (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|
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|
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||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Robert M Kacmarek, PhD, RRT 617-724-4480 email@example.com|
|Contact: Demet S Sulemanji, MD 617-724 4498 firstname.lastname@example.org|
|Principal Investigator: Robert M Kacmarek, PhD, RRT|
|Sub-Investigator: Demet S Sulemanji, MD|
|Hospital Dr. Negrín||Not yet recruiting|
|Las Palmas de Gran Canaria, Gran Canaria, Spain|
|Contact: Jesus Villar, MD, PhD email@example.com|
|Principal Investigator: Jesus Villar, MD, PhD|
|Principal Investigator:||Robert M Kacmarek, PhD||Massachusetts General Hospital|
|Principal Investigator:||Jesus Villar, MD, PhD||H. Dr. Negrín, Las Palmas de Gran Canaria|