Clinical trial NCT00583037: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiration, Artificial
Respiratory Insufficiency
Keywords: Neurally Adjusted Ventilatory Assist
Sleep quality
Adult
Critical Care
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

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

Primary outcomes:
measure: 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
timeFrame: 24 hours
Secondary outcomes:
measure: 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
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St-Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Fabrice Brunet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Christer Sinderby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.