24-Hour NAVA Ventilation in Acute Respiratory Failure

May 29, 2009 updated by: Unity Health Toronto

FEASIBILITY OF 24 Hrs VENTILATION WITH NEURALLY ADJUSTED VENTILATORY ASSIST (NAVA) IN PATIENTS WITH ACUTE RESPIRATORY FAILURE

Neurally Adjusted Ventilatory Assist (NAVA) is a new mode of mechanical ventilation that is controlled by the electrical activity of the diaphragm (EAdi). The EAdi is a signal that represents the patient's breathing effort, and hence with NAVA, the assist being delivered is synchronized and proportional to the demands of the patient. This is a prospective physiological study of the feasibility of NAVA ventilation over 24 hours. The aim is to demonstrate that NAVA can maintain spontaneous breathing and unload the respiratory muscles during both sleep and wake cycles over a 24 hour period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To date, studies using NAVA technology have been limited to short term evaluations (under 3 hours). No serious adverse events have been observed in patients enrolled in our 3-hour study of NAVA in patients with acute lung injury. All 15 patients successfully tolerated the period of ventilation (i.e. there were no dropouts) with NAVA and the stability of the blood gas parameters over time reveals the efficiency of this new mode of ventilation in regards to oxygenation.

A longer study may help to evaluate patient tolerance of NAVA and stability over time. A longer study will also demonstrate the feasibility of NAVA to adapt to changes in respiratory drive, changes in patient status, and the interventions of health care providers. A longer time frame should help us understand the parameters for titration of NAVA settings over time and establish some indications/limits for the future use of this promising technique. This intermediate study will generate the data necessary for the development of additional protocols to refine NAVA application and to compare NAVA to other assist modes.

Study Type

Interventional

Enrollment (Anticipated)

15

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • St-Michael's Hospital

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:

  • Patients admitted to the ICU will be screened on a daily basis for the presence of the following characteristics:

  • Adult (>18 years old) intubated and mechanically ventilated patients with evidence of spontaneous breathing defined as:

    1. Patient is on pressure support ventilation OR
    2. Patient is on pressure control ventilation with the ability to trigger 50% of the breaths.
  • Sedation Agitation Score (SAS) score greater than or equal to 2
  • Presence of an arterial line
  • Patients meeting these criteria will be considered eligible for recruitment into the study

General Exclusion Criteria:

  • Next of kin unavailable
  • Patient/next of kin refuses informed consent.
  • Attending physician refuses to allow enrollment
  • Pregnancy

Exclusion Criteria Related to the Technique:

  • Any contraindication to insertion of a nasogastric tube including, but not limited to: severe oropharyngeal malformation or bleeding, esophageal varices, tumor, infection, stenosis, or rupture
  • Hemophilia or other severe bleeding disorder
  • Presence or suspicion of central/brain stem neurologic disorder/severe neuromuscular disease
  • Treatment with neuromuscular blockers
  • History of heart and/or lung transplantation

Exclusion Criteria Related to the Clinical Stability of the Patient:

  • Mean arterial blood pressure < 60 mm Hg with or without vasopressors or inotropes
  • Any contraindication to reducing sedation to obtain a targeted SAS score of 3 (e.g. anticipated hemodynamic instability after reduction of sedation)
  • Patients with evidence of any of the above exclusions will not be eligible for enrollment in this study

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: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NAVA
Implementation of NAVA for 24 hours
Device: Neurally Adjusted Ventilatory Assist (NAVA)
Mechanical ventilation controlled by diaphragm electrical activity
Other Names:
  • Servo i Ventilator System- NAVA Catheters (6671277, 6671280, 6671282, 6671287, 6671290)
  • Servo i Ventilator System- NAVA HW option (6671957)
  • Servo i Ventilator System- NAVA SW option (6671965)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of NAVA as assessed by: • Assessment of FiO2 changes • Assessment of the NAVA catheter function: o Stability of the EAdi signal from NAVA catheter o Requirements for NAVA catheter position change • Reasons for ventilator alarms
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient tolerance of NAVA as assessed by: • Changes in SAS scoring and sedation requirement • Changes in vital signs (HR/BP) and vasopressors requirements • Changes in oxygenation/ventilation
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Fabrice Brunet, MD, Unity Health Toronto

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, 2006

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (ESTIMATE)

December 31, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2009

Last Update Submitted That Met QC Criteria

May 29, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-242

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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