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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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 Clinic of 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
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Hospital Santiago, S. de Compostela
Hospital General Universitario Morales Meseguer
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
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 Clinic of 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
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Hospital Santiago, S. de Compostela
Hospital General Universitario Morales Meseguer
Hospital Uppsala
Investigators
Principal Investigator: Robert M Kacmarek, PhD Massachusetts General Hospital
Principal Investigator: Jesus Villar, MD, PhD H. Dr. Negrín, Las Palmas de Gran Canaria
  More Information

No publications provided

Responsible Party: Robert M. Kacmarek, Professor of Anesthesia, Director of Respiratory Care Services, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01730794     History of Changes
Other Study ID Numbers: 2012P002419
Study First Received: November 15, 2012
Last Updated: November 26, 2012
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Acute Respiratory Failure
Mechanical Ventilation
NAVA
Lung protective ventilation
invasive ventilation
noninvasive ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on July 31, 2014