24-Hour NAVA Ventilation in Acute Respiratory Failure

This study has been completed.
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00583037
First received: December 20, 2007
Last updated: May 29, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Respiration, Artificial
Respiratory Insufficiency
Device: Neurally Adjusted Ventilatory Assist (NAVA)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: FEASIBILITY OF 24 Hrs VENTILATION WITH NEURALLY ADJUSTED VENTILATORY ASSIST (NAVA) IN PATIENTS WITH ACUTE RESPIRATORY FAILURE

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: May 2006
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583037

Locations
Canada, Ontario
St-Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Fabrice Brunet, MD St. Michael's Hospital, Toronto
Principal Investigator: Christer Sinderby, PhD St. Michael's Hospital, Toronto
  More Information

Publications:
Responsible Party: Fabrice Brunet, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00583037     History of Changes
Other Study ID Numbers: 05-242
Study First Received: December 20, 2007
Last Updated: May 29, 2009
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Neurally Adjusted Ventilatory Assist
Sleep quality
Adult
Critical Care

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on August 21, 2014