Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT01730794
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2012-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute Respiratory Failure
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: