Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT01730794|
Recruitment Status : Recruiting
First Posted : November 21, 2012
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure||Other: NAVA ventilation Other: Conventional Lung Protective Ventilation||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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
conventional protective mechanical 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
Neurally adjusted ventilatory assist
- Number of invasive ventilator free days. [ Time Frame: 90 Days ]Number of days without mechanical ventilation, within the first 28 days of the study.
- Total length of mechanical ventilation (invasive plus noninvasive) [ Time Frame: 90 Days ]Total number of days of mechanical ventilation.
- Length of ICU stay [ Time Frame: 90 Days ]Total number of days of ICU stay.
- Length of hospital stay [ Time Frame: 90 Days ]Total number of days of Hospital stay.
- Mortality [ Time Frame: 90 Days ]Mortality within 90 days
- Ventilator associated pneumonia [ Time Frame: 90 Days ]Number of diagnosed Ventilator Associated Pneumonia
- Incidence of barotrauma [ Time Frame: 90 Days ]Number of diagnosed Barotrauma
- Development of Acute respiratory distress syndrome (ARDS) [ Time Frame: 90 Days ]Number of patients developing ARDS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730794
|Contact: Robert M Kacmarek, PhD, RRT||617-724 firstname.lastname@example.org|
|Contact: Demet S Sulemanji, MD||617-724 email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Withdrawn|
|Boston, Massachusetts, United States, 02114|
|Hospital Clinico de Valencia||Recruiting|
|Contact: Javier Belda, MD, PhD firstname.lastname@example.org|
|Contact: Carlos Ferrando, MD, PhD email@example.com|
|Principal Investigator:||Robert M Kacmarek, PhD||Massachusetts General Hospital|
|Principal Investigator:||Jesus Villar, MD, PhD||H. Dr. Negrín, Las Palmas de Gran Canaria|