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

This study is currently recruiting participants.
Verified September 2016 by Robert M. Kacmarek, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730794
First Posted: November 21, 2012
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Dr. Negrin University Hospital
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
  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: None (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 Robert M. Kacmarek, Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of invasive ventilator free days. [ Time Frame: 90 Days ]
    Number of days without mechanical ventilation, within the first 28 days of the study.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 306
Study Start Date: March 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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 Withdrawn
Boston, Massachusetts, United States, 02114
Spain
Hospital Clinico de Valencia Recruiting
Valencia, Spain
Contact: Javier Belda, MD, PhD       fco.javier.belda@uv.es   
Contact: Carlos Ferrando, MD, PhD       cafeoranestesia@gmail.com   
Sponsors and Collaborators
Massachusetts General Hospital
Dr. Negrin University Hospital
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: November 15, 2012
First Posted: November 21, 2012
Last Update Posted: September 19, 2017
Last Verified: September 2016

Keywords provided by Robert M. Kacmarek, Massachusetts General Hospital:
Acute Respiratory Failure
Mechanical Ventilation
NAVA
Lung protective ventilation
invasive ventilation
noninvasive ventilation

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