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

NCT ID: NCT01730794

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-28
• Study Completion Date: 2020-01-22

Brief Summary

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.

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).

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Conventional Lung Protective Ventilation

Intervention Type: OTHER

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.

Group Type: OTHER

NAVA ventilation

Intervention Type: OTHER

Neurally adjusted ventilatory assist

Interventions

NAVA ventilation

Neurally adjusted ventilatory assist

Intervention Type: OTHER

Conventional Lung Protective Ventilation

conventional protective mechanical ventilation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Negrin University Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Kacmarek

Professor of Anesthesia, Director of Respiratory Care Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert M Kacmarek, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Jesus Villar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain

Locations

Nanjing Zhongda Hospital Southeast University

Nanjing, , China

Hospital Universitario NS de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Hospital NS del Prado

Talavera de la Reina, Toledo, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Hospital Virgen de la Luz

Cuenca, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Fundación Jiménez Díaz

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Morales Meseguer

Murcia, , Spain

Hospital Universitario Virgen de Arrixaca

Murcia, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Hospital Clinico de Valencia

Valencia, , Spain

Hospital Universitario Rio Hortega

Valladolid, , Spain

Hospital Txagorritxu

Vitoria-Gasteiz, Álava, Spain

Countries

China; Spain

References

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.

Reference Type: DERIVED

PMID: 27737690 (View on PubMed)

Other Identifiers

2012P002419

Identifier Type: -

Identifier Source: org_study_id