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

This study is not yet open for participant recruitment.

Verified November 2012 by Massachusetts General Hospital

Sponsor:

Collaborators:

Hospital Dr. Negrín, Las Palmas de Gran Canaria

Hospital del Prado, Talavera de la Reina

Hospital Rio Hortega, Valladolid

Hospital Virgen de la Luz, Cuenca

Hospital Clínico, Barcelona

Hospital Galdakao, Bilbao

Hospital Parc Taulí, Sabadell

Hospital Río Hortega, Valladolid

Hospital Clínico, Valencia

Hospital de León, León

Hospital Virgen de la Salud, Toledo

Hospital Txagorritxu, Vitoria

Hospital Candelaria, Santa Cruz de Tenerife

Hospital Trieste, Italy

Hospital Virgen del Rocío, Sevilla

Hospital Virgen de la Arrixaca, Murcia

Hospital Clínico, Madrid

Hospital de la Coruña, La Coruña

Hospital La Mancha, Alcázar de San Juan

Hospital Universitario Ramon y Cajal

Fundación Jiménez Díaz, Madrid

Hospital Santiago, S. de Compostela

Hospital Morales Meseguer, Murcia

Hospital Uppsala

Information provided by (Responsible Party):

Robert M. Kacmarek, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01730794

First received: November 15, 2012

Last updated: November 26, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition	Intervention
Acute Respiratory Failure	Other: NAVA ventilation Other: Conventional Lung Protective Ventilation

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Number of invasive ventilator free days. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total length of mechanical ventilation (invasive plus noninvasive) [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
Length of ICU stay [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
Length of hospital stay [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
Ventilator associated pneumonia [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
Incidence of barotrauma [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
Development of Acute respiratory distress syndrome (ARDS) [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	306
Study Start Date:	January 2013
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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

Arms

Assigned Interventions

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

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

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 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.

Primary Outcome

• Number of invasive ventilator free days.

Secondary Outcome

Total mechanical ventilation (invasive plus noninvasive) free days
Mortality
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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than or equal to 18 years
Hypoxemic or hypercapnic acute respiratory failure
Intubation and mechanical ventilation
Anticipated mechanical ventilation longer than 72 hrs
Mechanically ventilated < 48 hours
Able to spontaneously trigger the ventilator

Exclusion Criteria:

Acute respiratory distress syndrome
Post-operative patient's normally requiring a short course of mechanical ventilation (for example most cardiac surgical patients)
Equal to or greater than 3 total organ failures
Unable to spontaneously breathe
Need to provide controlled ventilation
Poor short term prognosis (defined as a high risk of death in the next 3 months)
Neuromuscular or neurologic disease
Age < 18 years
Weight < 35 kg predicted body weight (PBW).
Patients with major esophageal, gastric and oral surgery
Body mass index > 50
Acute brain injury or elevated intracranial pressure (> 18 mmHg)
Immunosuppressed patients receiving chemotherapy or radiation therapy (less than 2 month after chemotherapy or radiation therapy).
Severe cardiac disease: New York Heart Association class 3 or 4 or acute coronary syndrome or persistent ventricular tachyarrhythmias.
Pregnancy, must be confirmed by laboratory analysis.
Sickle cell disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730794

Contacts

Contact: Robert M Kacmarek, PhD, RRT	617-724 4480	rkacmarek@partners.org
Contact: Demet S Sulemanji, MD	617-724 4498	dsulemanji@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Robert M Kacmarek, PhD, RRT 617-724-4480 rkacmarek@partners.org
Contact: Demet S Sulemanji, MD 617-724 4498 dsulemanji@partners.org
Principal Investigator: Robert M Kacmarek, PhD, RRT
Sub-Investigator: Demet S Sulemanji, MD
Spain
Hospital Dr. Negrín	Not yet recruiting
Las Palmas de Gran Canaria, Gran Canaria, Spain
Contact: Jesus Villar, MD, PhD jesus.villar54@gmail.com
Principal Investigator: Jesus Villar, MD, PhD

Sponsors and Collaborators

Massachusetts General Hospital