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

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NAVA ventilation
Conventional Lung Protective Ventilation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Acute Respiratory Failure, Mechanical Ventilation, NAVA, Lung protective ventilation, invasive ventilation, noninvasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nanjing Zhongda Hospital Southeast University
  • Hospital Universitario NS de Candelaria
  • Hospital NS del Prado
  • Complejo Hospitalario Universitario de Albacete
  • Hospital Virgen de la Luz
  • Hospital Universitario Ramón y Cajal
  • Hospital Fundación Jiménez Díaz
  • Hospital Universitario La Paz
  • Hospital Universitario Morales Meseguer
  • Hospital Universitario Virgen de Arrixaca
  • Hospital Virgen de la Salud
  • Hospital Clinico de Valencia
  • Hospital Universitario Rio Hortega
  • Hospital Txagorritxu

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Conventional Lung Protective Ventilation

NAVA Ventilation Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
November 15, 2012
Last Updated
January 23, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Dr. Negrin University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01730794
Brief Title
Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute Respiratory Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2014 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dr. Negrin University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Acute Respiratory Failure, Mechanical Ventilation, NAVA, Lung protective ventilation, invasive ventilation, noninvasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Lung Protective Ventilation
Arm Type
Other
Arm Description
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.
Arm Title
NAVA Ventilation Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NAVA ventilation
Intervention Description
Neurally adjusted ventilatory assist
Intervention Type
Other
Intervention Name(s)
Conventional Lung Protective Ventilation
Intervention Description
conventional protective mechanical ventilation
Primary Outcome Measure Information:
Title
Number of invasive ventilator free days.
Description
Number of days without mechanical ventilation, within the first 28 days of the study.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Total length of mechanical ventilation in survivors (invasive plus noninvasive)
Description
Total number of days of mechanical ventilation in ICU survivors.
Time Frame
90 days
Title
ICU and hospital Mortality
Description
Mortality during patient stay in the ICU and after being discharged from ICU
Time Frame
90 days
Title
Incidence of barotrauma
Description
Number of diagnosed pneumothorax
Time Frame
60 Days
Title
Ventilator associated pneumonia
Description
Number of diagnosed Ventilator Associated Pneumonia
Time Frame
60 Days
Title
Development of Acute respiratory distress syndrome (ARDS)
Description
Number of patients developing ARDS
Time Frame
60 Days
Title
Length of ICU stay
Description
Total number of days of ICU stay.
Time Frame
90 Days
Title
Length of hospital stay
Description
Total number of days of Hospital stay.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Kacmarek, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesus Villar, MD, PhD
Organizational Affiliation
Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Zhongda Hospital Southeast University
City
Nanjing
Country
China
Facility Name
Hospital Universitario NS de Candelaria
City
Santa Cruz De Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital NS del Prado
City
Talavera De La Reina
State/Province
Toledo
ZIP/Postal Code
45600
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Albacete
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Hospital Virgen de la Luz
City
Cuenca
ZIP/Postal Code
16002
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Hospital Clinico de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27737690
Citation
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.
Results Reference
derived

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

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