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Clinical Trials/NCT00529347
NCT00529347
Completed
Phase 1

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country20 target enrollmentSeptember 2007
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ConditionsMechanical Ventilation

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
20
Locations
1
Primary Endpoint
Change in diaphragmatic Edi (area under the curve) during expiration
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
July 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: At each intervention

Study Sites (1)

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