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

A Comparative, Multicenter, Randomized, Controlled Study of Neurally Adjusted Ventilatory Assist (NAVA) vs. Conventional Lung Protective Ventilation in Patients With Acute Respiratory Failure

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: Conventional Lung Protective Ventilation; 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 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).

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Nanjing Zhongda Hospital Southeast University
• Spain
  • Albacete, Spain, 02006
    • Complejo Hospitalario Universitario de Albacete
  • Cuenca, Spain, 16002
    • Hospital Virgen de la Luz
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Hospital Fundación Jiménez Díaz
  • Murcia, Spain, 30008
    • Hospital Universitario Morales Meseguer
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de Arrixaca
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain
    • Hospital Clinico de Valencia
  • Valladolid, Spain, 47012
    • Hospital Universitario Rio Hortega
  • Tenerife
    • Santa Cruz De Tenerife, Tenerife, Spain, 38010
      • Hospital Universitario NS de Candelaria
  • Toledo
    • Talavera De La Reina, Toledo, Spain, 45600
      • Hospital NS del Prado
  • Álava
    • Vitoria, Álava, Spain, 01007
      • Hospital Txagorritxu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than or equal to 18 years
• Hypoxemic or hypercapnic acute respiratory failure
• Intubation and mechanical ventilation
• Anticipated mechanical ventilation equal or longer than 72 hrs
• Mechanically ventilated less or equal to 5 days
• Able to spontaneously trigger the ventilator

Exclusion Criteria:

• moderate-to-severe acute respiratory distress syndrome
• Post-operative patient's normally requiring a short course of mechanical ventilation (for example most cardiac surgical patients)
• 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
• Patients with major esophageal, gastric and oral surgery
• Acute brain injury or elevated intracranial pressure (> 18 mmHg)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of invasive ventilator free days.	Number of days without mechanical ventilation, within the first 28 days of the study.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total length of mechanical ventilation in survivors (invasive plus noninvasive)	Total number of days of mechanical ventilation in ICU survivors.	90 days
ICU and hospital Mortality	Mortality during patient stay in the ICU and after being discharged from ICU	90 days
Incidence of barotrauma	Number of diagnosed pneumothorax	60 Days
Ventilator associated pneumonia	Number of diagnosed Ventilator Associated Pneumonia	60 Days
Development of Acute respiratory distress syndrome (ARDS)	Number of patients developing ARDS	60 Days
Length of ICU stay	Total number of days of ICU stay.	90 Days
Length of hospital stay	Total number of days of Hospital stay.	90 Days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Dr. Negrin University Hospital
• Investigators: Principal Investigator: Robert M Kacmarek, PhD, Massachusetts General Hospital; Principal Investigator: Jesus Villar, MD, PhD, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain

Publications and helpful links

General Publications

• Villar J, Belda J, Blanco J, Suarez-Sipmann F, Anon JM, Perez-Mendez L, Ferrando C, Parrilla D, Montiel R, Corpas R, Gonzalez-Higueras E, Pestana D, Martinez D, Fernandez L, Soro M, Garcia-Bello MA, Fernandez RL, Kacmarek RM; NAVa In Acute respiraTORy failure (NAVIATOR) Network. Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial. Trials. 2016 Oct 13;17(1):500. doi: 10.1186/s13063-016-1625-5.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2014
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: noninvasive ventilation; Mechanical Ventilation; invasive ventilation; NAVA; Acute Respiratory Failure; Lung protective ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: 2012P002419