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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01730794

Collaborator

Dr. Negrin University Hospital (Other)

306

Enrollment

Locations

Arms

69.8

Actual Duration (Months)

21.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure	Other: NAVA ventilation Other: Conventional Lung Protective Ventilation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

306 participants

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

Actual Study Start Date :

Mar 28, 2014

Actual Primary Completion Date :

Jan 22, 2020

Actual Study Completion Date :

Jan 22, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of invasive ventilator free days. [28 days]
Number of days without mechanical ventilation, within the first 28 days of the study.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing Zhongda Hospital Southeast University	Nanjing		China
2	Hospital Universitario NS de Candelaria	Santa Cruz De Tenerife	Tenerife	Spain	38010
3	Hospital NS del Prado	Talavera De La Reina	Toledo	Spain	45600
4	Complejo Hospitalario Universitario de Albacete	Albacete		Spain	02006
5	Hospital Virgen de la Luz	Cuenca		Spain	16002
6	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
7	Hospital Fundación Jiménez Díaz	Madrid		Spain	28040
8	Hospital Universitario La Paz	Madrid		Spain	28046
9	Hospital Universitario Morales Meseguer	Murcia		Spain	30008
10	Hospital Universitario Virgen de Arrixaca	Murcia		Spain	30120
11	Hospital Virgen de la Salud	Toledo		Spain	45004
12	Hospital Clinico de Valencia	Valencia		Spain
13	Hospital Universitario Rio Hortega	Valladolid		Spain	47012
14	Hospital Txagorritxu	Vitoria	Álava	Spain	01007

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