Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern

Mechanical Ventilation Clinical Trial

Official title:

The Effect of Positive End Expiratory Pressure (PEEP) on the Breathing Pattern During Neurally Adjusted Ventilatory Assist (NAVA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529347
• Other study ID #: SNF-3200B0-113478-1
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2007
• Last updated: September 7, 2009
• Start date: September 2007
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of changing ventilatory parameters on the patient's breathing pattern during NAVA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Invasive mechanical ventilation (tracheally intubated or tracheotomized)

• Presence of an arterial pressure line.

• Subject itself or its next of kin has given written informed consent

Exclusion Criteria:

• Patient is less than 18 years or more than 85 years of age

• The attending physician refuses to allow enrollment

• The patient refuses informed consent

• Next of kin is unavailable or refuses informed consent

• Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age.

• Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture

• Presence or suspicion of diaphragm injury

• Hemophilia or other severe bleeding disorder

• Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection

• History of heart and/or lung transplantation

• Any mechanical cardiac assist device (excluding intraaortic balloon pump)

• Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing

• The patient needs to be ventilated with a mode of mechanical ventilation that targets a predefined tidal volume or airway pressure as per attending physician

• Severe hemodynamic instability as per attending physician

• Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.

• A fraction of inspired oxygen (FiO2) of > 0.8

• The patient currently participates in another interventional clinical trial

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Device:
• neurally adjusted ventilatory assist (NAVA)
assessment of breathing pattern at various ventilator settings

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine, University Hospital - Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diaphragmatic Edi (area under the curve) during expiration		At each intervention	No