Performance of Neurally Adjusted Ventilatory Assist (NAVA) During Spontaneous Breathing Trial

September 11, 2013 updated by: University of Sao Paulo General Hospital

Performance of Neurally Adjusted Ventilatory Assist (NAVA) During an Spontaneous Breathing Trial

The purpose of this study is to compare a new mode of mechanical ventilation (NAVA, or Neurally adjusted Ventilatory assist) with a traditional mode (Pressure Support ventilation) on its the ability to detect patients ready for extubation (liberation from mechanical ventilation).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients under mechanical ventilation who are suspected to be recovered and ready to return to spontaneous ventilation often undergo an spontaneous breathing trial (SBT) before extubation and liberation from mechanical ventilation. During the test, which lasts from 30 minutes to 2 hours , the patient receives minimal support from the ventilator, and the ICU team observes if the patient develops any signs or symptoms of discomfort or respiratory distress. If the patient tolerates the test, he or she is considered ready for extubation. The Neurally Adjusted Ventilatory Assist (NAVA) is a new mode of ventilation, shown to improve patient-ventilator synchrony. It has not been tested during SBTs. Our objective is to compare the performance of NAVA with the commonly used Pressure Support ventilation, during an SBT. Patients considered to be ready for an SBT by the ICU team will undergo two SBTs in random order: one in pressure support, and the other on NAVA, with a 1-hour interval between the tests. Ventilatory parameters and patient-ventilator interaction variables will be compared among the two tests.

This study will help us understand if NAVA can be used during an SBT, which might be important for patients who are being ventilated with NAVA before the SBT is suggested, especially those how present a high asynchrony rate when ventilated with Pressure Support Mode.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Respiratory ICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mechanical ventilation for more than 48 hours
  • Considered ready for an spontaneous breathing trial by the ICU team
  • informed consent for participation on the study signed by a family member

Exclusion Criteria:

  • age < 18yrs
  • pregnancy
  • facial trauma or burns that might interfere with the esophageal catheter placement
  • nasal pathologies that prevent adequate placement of the catheter
  • esophageal varices or gastroesophageal bleeding in the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PSV
Procedure: SBT- PSV
An Spontaneous breathing trial for 30 minutes on pressure support ventilation, which is a commonly used strategy to evaluate readiness for extubation
Other Names:
  • SBT
Procedure: SBT - NAVA
An spontaneous breathing trial (SBT) on the ventilatory mode NAVA, with ventilatory support titrated to be similar to the support provided during an SBT on pressure support mode (PSV). NAVA captures the electrical activity of the diaphragm with an esophageal-gastric catheter, and uses the electrical signal to deliver inspiratory pressure proportional to the intensity of patient effort, as well as to trigger and cycle assisted mechanical breaths.
Other Names:
  • NAVA
  • N.A.V.A.
Experimental: NAVA
Procedure: SBT- PSV
An Spontaneous breathing trial for 30 minutes on pressure support ventilation, which is a commonly used strategy to evaluate readiness for extubation
Other Names:
  • SBT
Procedure: SBT - NAVA
An spontaneous breathing trial (SBT) on the ventilatory mode NAVA, with ventilatory support titrated to be similar to the support provided during an SBT on pressure support mode (PSV). NAVA captures the electrical activity of the diaphragm with an esophageal-gastric catheter, and uses the electrical signal to deliver inspiratory pressure proportional to the intensity of patient effort, as well as to trigger and cycle assisted mechanical breaths.
Other Names:
  • NAVA
  • N.A.V.A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of success on the spontaneous breathing trial
Time Frame: 30 minutes, or earlier (if the SBT is interrupted for intolerance), i.e., at the end of the spontaneous breathing trial
The ICU team will observe the patient during the spontaneous breathing trial, and use standard objective (blood gases) and subjective (including respiratory rate, tidal volume, comfort, hemodynamic variables) variables to determine if the patient tolerates the SBT and therefore is ready for discontinuation from mechanical ventilation
30 minutes, or earlier (if the SBT is interrupted for intolerance), i.e., at the end of the spontaneous breathing trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation failure rate
Time Frame: 48 hours after extubation
Patients who are extubated within 24 hours of the completion of the study will be followed for 48h, and if re-intubation is required within these first 48h after the extubation, the investigators will consider that the patient had extubation failure
48 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Estimate)

September 12, 2013

Last Update Submitted That Met QC Criteria

September 11, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-345

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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