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24-Hour NAVA Ventilation in Acute Respiratory Failure

Primary Purpose

Respiration, Artificial, Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neurally Adjusted Ventilatory Assist (NAVA)
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiration, Artificial focused on measuring Neurally Adjusted Ventilatory Assist, Sleep quality, Adult, Critical Care

Eligibility Criteria

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

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

Sites / Locations

  • St-Michael's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAVA

Arm Description

Implementation of NAVA for 24 hours

Outcomes

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

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

Full Information

First Posted
December 20, 2007
Last Updated
May 29, 2009
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00583037
Brief Title
24-Hour NAVA Ventilation in Acute Respiratory Failure
Official Title
FEASIBILITY OF 24 Hrs VENTILATION WITH NEURALLY ADJUSTED VENTILATORY ASSIST (NAVA) IN PATIENTS WITH ACUTE RESPIRATORY FAILURE
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial, Respiratory Insufficiency
Keywords
Neurally Adjusted Ventilatory Assist, Sleep quality, Adult, Critical Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAVA
Arm Type
Experimental
Arm Description
Implementation of NAVA for 24 hours
Intervention Type
Device
Intervention Name(s)
Neurally Adjusted Ventilatory Assist (NAVA)
Other Intervention Name(s)
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)
Intervention Description
Mechanical ventilation controlled by diaphragm electrical activity
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Patient is on pressure support ventilation OR 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Brunet, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christer Sinderby, PhD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St-Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10581089
Citation
Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.
Results Reference
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PubMed Identifier
14522808
Citation
Sinderby C. Ventilatory assist driven by patient demand. Am J Respir Crit Care Med. 2003 Oct 1;168(7):729-30. doi: 10.1164/rccm.2307004. No abstract available.
Results Reference
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PubMed Identifier
17960364
Citation
Beck J, Brander L, Slutsky AS, Reilly MC, Dunn MS, Sinderby C. Non-invasive neurally adjusted ventilatory assist in rabbits with acute lung injury. Intensive Care Med. 2008 Feb;34(2):316-23. doi: 10.1007/s00134-007-0882-x. Epub 2007 Oct 25.
Results Reference
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PubMed Identifier
17314685
Citation
Beck J, Campoccia F, Allo JC, Brander L, Brunet F, Slutsky AS, Sinderby C. Improved synchrony and respiratory unloading by neurally adjusted ventilatory assist (NAVA) in lung-injured rabbits. Pediatr Res. 2007 Mar;61(3):289-94. doi: 10.1203/01.pdr.0000257324.22406.93.
Results Reference
background
PubMed Identifier
16957635
Citation
Allo JC, Beck JC, Brander L, Brunet F, Slutsky AS, Sinderby CA. Influence of neurally adjusted ventilatory assist and positive end-expiratory pressure on breathing pattern in rabbits with acute lung injury. Crit Care Med. 2006 Dec;34(12):2997-3004. doi: 10.1097/01.CCM.0000242520.50665.9F.
Results Reference
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24-Hour NAVA Ventilation in Acute Respiratory Failure

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