24-Hour NAVA Ventilation in Acute Respiratory Failure

NCT00583037 | Completed

• 1 other identifier: 05-242
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration, Artificial; Respiratory Insufficiency

Keywords

Neurally Adjusted Ventilatory Assist; Sleep quality; Adult; Critical Care

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (1)

• 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

  24 hours

Study Arms (1)

NAVA

EXPERIMENTAL

Implementation of NAVA for 24 hours

Device: Neurally Adjusted Ventilatory Assist (NAVA)

Interventions

Neurally Adjusted Ventilatory Assist (NAVA) DEVICE

Mechanical ventilation controlled by diaphragm electrical activity

Also known as: 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)

NAVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St-Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (5)

• 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.

  PMID: 10581089 BACKGROUND

• 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.

  PMID: 14522808 BACKGROUND

• 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.

  PMID: 17960364 BACKGROUND

• 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.

  PMID: 17314685 BACKGROUND

• 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.

  PMID: 16957635 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Insufficiency; Sleep Initiation and Maintenance Disorders

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Fabrice Brunet, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Christer Sinderby, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: May 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 1, 2009

Record last verified: 2009-05

Locations

CA (1)