24-Hour NAVA Ventilation in Acute Respiratory Failure

Respiratory Insufficiency Clinical Trial

Official title:

FEASIBILITY OF 24 Hrs VENTILATION WITH NEURALLY ADJUSTED VENTILATORY ASSIST (NAVA) IN PATIENTS WITH ACUTE RESPIRATORY FAILURE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583037
• Other study ID #: 05-242
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: May 29, 2009
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2009
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiration, Artificial
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Neurally Adjusted Ventilatory Assist (NAVA)
Mechanical ventilation controlled by diaphragm electrical activity

Locations

Country	Name	City	State
Canada	St-Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. Epub 2007 Oct 25. — View 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. — View Citation

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. — View Citation

Sinderby C. Ventilatory assist driven by patient demand. Am J Respir Crit Care Med. 2003 Oct 1;168(7):729-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes