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Clinical Trials/NCT01280383
NCT01280383
Withdrawn
Phase 1

Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial

Insel Gruppe AG, University Hospital Bern0 sitesNovember 2010
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ConditionsRespiratory Failure

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Insel Gruppe AG, University Hospital Bern
Primary Endpoint
patient-ventilator synchrony
Status
Withdrawn
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.

Detailed Description

To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age 18 - 85 years
  • •History of chronic obstructive lung disease
  • •Invasive mechanical ventilation for more than 12 hours
  • •Planned extubation according to the weaning protocol of our clinic
  • •Informed consent obtained from a next of kin
  • •Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient

Exclusion Criteria

  • •Tracheostomy
  • •Facial or cranial trauma or surgery
  • •Oral, esophageal, diaphragmatic or gastric trauma or surgery
  • •Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
  • •Uncooperative state and combativeness not responding to low levels of sedatives
  • •Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
  • •Next of kin refuses informed consent
  • •Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.

Outcomes

Primary Outcomes

patient-ventilator synchrony

Time Frame: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes

Secondary Outcomes

  • changes in respiratory pattern(study duration)

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