24-Hour NAVA Ventilation in Acute Respiratory Failure

NCT ID: NCT00583037

Last Updated: 2009-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-05-31

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.

Conditions

Respiration, Artificial; Respiratory Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

NAVA

Implementation of NAVA for 24 hours

Group Type: EXPERIMENTAL

Neurally Adjusted Ventilatory Assist (NAVA)

Intervention Type: DEVICE

Mechanical ventilation controlled by diaphragm electrical activity

Interventions

Neurally Adjusted Ventilatory Assist (NAVA)

Mechanical ventilation controlled by diaphragm electrical activity

Intervention Type: DEVICE

Other Intervention 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)

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:

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

Exclusion Criteria

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

St. Michael's Hospital

Principal Investigators

Fabrice Brunet, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Christer Sinderby, PhD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St-Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 10581089 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14522808 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17960364 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17314685 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16957635 (View on PubMed)

Other Identifiers

05-242

Identifier Type: -

Identifier Source: org_study_id