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Clinical Trials/NCT02473172
NCT02473172
Completed
Phase 2

Impact of Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) Diaphragm Efficiency

University of Bari1 site in 1 country38 target enrollmentMay 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
University of Bari
Enrollment
38
Locations
1
Primary Endpoint
Diaphragm neuro-ventilatory efficiency (NVE)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study evaluates the impact of the assisted mode of mechanical ventilation on diaphragm efficiency in mechanically ventilated critically ill patients. Participants will be randomized to the neurally adjusted ventilatory assist (NAVA) mode or to the pressure support ventilation (PSV) mode.

Detailed Description

During mechanical ventilation the ventilator applies positive pressure to the respiratory system. Often in the acute phase of critical illness patients are ventilated in the control mode (CMV), where the patient is completely passive. This quickly (within 48 hours) has been shown to induce diaphragm atrophy and dysfunction (Levine et al New England Journal of Medicine, 200; 358:1327-35). To preserve diaphragm function, guidelines suggest to shift as soon as possible to the assisted mode (the ventilator applies positive pressure to assist spontaneous inspiratory effort). The synchrony between patient and ventilator is critical in this context. PSV is the classical assisted mode and applies a constant pressure whatever the patient effort. NAVA is a newer mode based on the diaphragm electrical activity (EAdi) measurement. It assist patient effort proportionally to the EAdi and hence to patient's effort. The investigator hypothesis is that NAVA would improve diaphragm efficiency more efficiently than PSV.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Bari
Responsible Party
Principal Investigator
Principal Investigator

Salvatore Grasso

Associate Professor

University of Bari

Eligibility Criteria

Inclusion Criteria

  • older than 18 years
  • oro-tracheally or naso-tracheally intubate
  • had been ventilated for acute respiratory failure in control mechanical ventilation for at least 72 hours consecutively
  • candidate to assisted ventilation
  • Hemodynamically stable without vasopressor or inotropes (excluding a dobutamine and dopamine infusion lower than 5 gamma/Kg/min and a 3 gamma /Kg/min, respectively
  • normothermia

Exclusion Criteria

  • Neurological or neuromuscular pathologies
  • phrenic nerve dysfunction
  • contraindications to the insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, esophageal varices).

Outcomes

Primary Outcomes

Diaphragm neuro-ventilatory efficiency (NVE)

Time Frame: 48 hours

Diaphragm neuro-ventilatory efficiency (NVE) to convert the electrical diaphragm activity (EAdi) into volume. NVE is impaired by controlled mechanical ventilation (CMV) and the assisted mode should serve to restore it. All the studied patents were ventilated for more than 48 hours in CMV, a period shown to be sufficient to induce diaphragm atrophy and therefore depress NVE. NVE is measured by the ratio between tidal volume (VT) and the EAdi peak (NVEpeak) or by the ratio between VT and the are under the EAdi signal. EAdi is obtained by the EAdi catheter, a nasogastric catheter equipped with electrodes (Maquet Critical Care, Solna, Sweden). EAdi is measured in microVolt. The Servo i ventilator (Maquet Critical Care, Solna Sweden) is equipped with a module able to amplify and show on a screen the EAdi trace and the corresponding value. Both the Servo i ventilator and the EAdi catheter are approved for clinical use.

Secondary Outcomes

  • Diaphragm neuro-mechanical efficiency (NME)(48 hours)

Study Sites (1)

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