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OpenTrials
Completed

NCT Number: NCT00529347

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Intensive Care Medicine, University Hospital - Inselspital

Bern, Canton of Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurally Adjusted Ventilatory Assist (NAVA)

Device

assessment of breathing pattern at various ventilator settings

Primary outcomes

  1. Change in diaphragmatic Edi (area under the curve) during expiration

    Time frame: At each intervention

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2007
Registry last updated
Sep 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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