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Impact of the Assisted Ventilation Mode on Diaphragm Efficiency in Critically Ill Patients (NAVA_PSV)

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ClinicalTrials.gov Identifier: NCT02473172
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Salvatore Grasso, University of Bari

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Pressure Support ventilation Device: Neurally Adjusted Ventilatory Assist Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) Diaphragm Efficiency
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Pressure Support Ventilation
Assisted mechanical ventilation
Device: Pressure Support ventilation
Assisted mechanical ventilation

Experimental: Neurally Adjusted Ventilatory Assist
Assisted mechanical ventilation
Device: Neurally Adjusted Ventilatory Assist
Assisted mechanical ventilation




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Diaphragm neuro-mechanical efficiency (NME) [ Time Frame: 48 hours ]

    Diaphragm neuro-mechanical efficiency (NME) to convert the electrical diaphragm activity (EAdi) into negative pressure is impaired by controlled mechanical ventilation (CMV). The assisted mode should serve to restore it. All the studied patents are ventilated for more than 48 hours in CMV, a period shown to be sufficient to induce diaphragm atrophy and hence depress NME.

    NME is measured by simultaneously recording EAdi and airway opening pressure during an end-expiratory airway opening occlusion and expressed in centimeters of waters (cmH2O)/microVolt.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473172


Locations
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Italy
Azienda Ospedaliero Universitaria Policlinico
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
Investigators
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Principal Investigator: Salvatore Grasso, Prof University of Bari, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Salvatore Grasso, Associate Professor, University of Bari
ClinicalTrials.gov Identifier: NCT02473172    
Other Study ID Numbers: NAVA_PSV
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Salvatore Grasso, University of Bari:
Weaning from mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases