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.
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 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 * Mortality * Length of Invasive Ventilation in survivors * Length of ICU and hospital stay * 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Neurally adjusted ventilatory assist
conventional protective mechanical ventilation
Nanjing Zhongda Hospital Southeast University
Nanjing, China
Hospital Universitario NS de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital NS del Prado
Talavera de la Reina, Toledo, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital Virgen de la Luz
Cuenca, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario Virgen de Arrixaca
Murcia, Spain
...and 4 more locations
Number of invasive ventilator free days.
Number of days without mechanical ventilation, within the first 28 days of the study.
Time frame: 28 days
Total length of mechanical ventilation in survivors (invasive plus noninvasive)
Total number of days of mechanical ventilation in ICU survivors.
Time frame: 90 days
ICU and hospital Mortality
Mortality during patient stay in the ICU and after being discharged from ICU
Time frame: 90 days
Incidence of barotrauma
Number of diagnosed pneumothorax
Time frame: 60 Days
Ventilator associated pneumonia
Number of diagnosed Ventilator Associated Pneumonia
Time frame: 60 Days
Development of Acute respiratory distress syndrome (ARDS)
Number of patients developing ARDS
Time frame: 60 Days
Length of ICU stay
Total number of days of ICU stay.
Time frame: 90 Days
Length of hospital stay
Total number of days of Hospital stay.
Time frame: 90 Days
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