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NCT Number: NCT01730794

Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults 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.

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Zhongda Hospital Southeast University, Nanjing, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAVA ventilation

Other

Neurally adjusted ventilatory assist

Conventional Lung Protective Ventilation

Other

conventional protective mechanical ventilation

Primary outcomes

  1. Number of invasive ventilator free days.

    Time frame: 28 days

    Number of days without mechanical ventilation, within the first 28 days of the study.

Secondary outcomes

  1. Total length of mechanical ventilation in survivors (invasive plus noninvasive)

    Time frame: 90 days

    Total number of days of mechanical ventilation in ICU survivors.

  2. ICU and hospital Mortality

    Time frame: 90 days

    Mortality during patient stay in the ICU and after being discharged from ICU

  3. Incidence of barotrauma

    Time frame: 60 Days

    Number of diagnosed pneumothorax

  4. Ventilator associated pneumonia

    Time frame: 60 Days

    Number of diagnosed Ventilator Associated Pneumonia

  5. Development of Acute respiratory distress syndrome (ARDS)

    Time frame: 60 Days

    Number of patients developing ARDS

  6. Length of ICU stay

    Time frame: 90 Days

    Total number of days of ICU stay.

  7. Length of hospital stay

    Time frame: 90 Days

    Total number of days of Hospital stay.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Hospital Universitario de Gran Canaria Doctor Negrín

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2012
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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