Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Acute Respiratory Failure
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency

Clinical Trial Details

NCT number	NCT01730794
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	March 28, 2014
Completion date	January 22, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute Respiratory Failure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms