An interventional study of NAVA ventilation and Conventional Lung Protective Ventilation in Acute Respiratory Failure, sponsored by Massachusetts General Hospital. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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
Secondary Outcome
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 306 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
conventional protective mechanical ventilation
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
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital