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

Insel Gruppe AG, University Hospital Bern

Status and phase

Completed

Phase 1

Conditions

Mechanical Ventilation

Treatments

Device: neurally adjusted ventilatory assist (NAVA)

Study type

Interventional

Funder types

Other

Identifiers

NCT00529347

SNF-3200B0-113478-1

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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