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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00529347
Enrollment
20
Registered
2007-09-14
Start date
2007-09-30
Completion date
2009-07-31
Last updated
2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Brief 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.

Interventions

assessment of breathing pattern at various ventilator settings

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in diaphragmatic Edi (area under the curve) during expirationAt each intervention

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026