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

Acute Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730794
• Other study ID #: 2012P002419
• Status: Completed
• Phase: N/A
• Start date: March 28, 2014
• Est. completion date: January 22, 2020

Study information

• Verified date: January 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Other:
• NAVA ventilation
Neurally adjusted ventilatory assist
• Conventional Lung Protective Ventilation
conventional protective mechanical ventilation

Locations

Country	Name	City	State
China	Nanjing Zhongda Hospital Southeast University	Nanjing
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital Virgen de la Luz	Cuenca
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Morales Meseguer	Murcia
Spain	Hospital Universitario Virgen de Arrixaca	Murcia
Spain	Hospital Universitario NS de Candelaria	Santa Cruz De Tenerife	Tenerife
Spain	Hospital NS del Prado	Talavera De La Reina	Toledo
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Clinico de Valencia	Valencia
Spain	Hospital Universitario Rio Hortega	Valladolid
Spain	Hospital Txagorritxu	Vitoria	Álava

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dr. Negrin University Hospital

Countries where clinical trial is conducted

China,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of invasive ventilator free days.	Number of days without mechanical ventilation, within the first 28 days of the study.	28 days
Secondary	Total length of mechanical ventilation in survivors (invasive plus noninvasive)	Total number of days of mechanical ventilation in ICU survivors.	90 days
Secondary	ICU and hospital Mortality	Mortality during patient stay in the ICU and after being discharged from ICU	90 days
Secondary	Incidence of barotrauma	Number of diagnosed pneumothorax	60 Days
Secondary	Ventilator associated pneumonia	Number of diagnosed Ventilator Associated Pneumonia	60 Days
Secondary	Development of Acute respiratory distress syndrome (ARDS)	Number of patients developing ARDS	60 Days
Secondary	Length of ICU stay	Total number of days of ICU stay.	90 Days
Secondary	Length of hospital stay	Total number of days of Hospital stay.	90 Days