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

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Pressure Support ventilation
Neurally Adjusted Ventilatory Assist
Sponsored by
University of Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Weaning from mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Azienda Ospedaliero Universitaria Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pressure Support Ventilation

Neurally Adjusted Ventilatory Assist

Arm Description

Assisted mechanical ventilation

Assisted mechanical ventilation

Outcomes

Primary Outcome Measures

Diaphragm neuro-ventilatory efficiency (NVE)
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

Diaphragm neuro-mechanical efficiency (NME)
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.

Full Information

First Posted
June 8, 2015
Last Updated
June 11, 2015
Sponsor
University of Bari
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1. Study Identification

Unique Protocol Identification Number
NCT02473172
Brief Title
Impact of the Assisted Ventilation Mode on Diaphragm Efficiency in Critically Ill Patients
Acronym
NAVA_PSV
Official Title
Impact of Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) Diaphragm Efficiency
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bari

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Weaning from mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure Support Ventilation
Arm Type
Experimental
Arm Description
Assisted mechanical ventilation
Arm Title
Neurally Adjusted Ventilatory Assist
Arm Type
Experimental
Arm Description
Assisted mechanical ventilation
Intervention Type
Device
Intervention Name(s)
Pressure Support ventilation
Intervention Description
Assisted mechanical ventilation
Intervention Type
Device
Intervention Name(s)
Neurally Adjusted Ventilatory Assist
Intervention Description
Assisted mechanical ventilation
Primary Outcome Measure Information:
Title
Diaphragm neuro-ventilatory efficiency (NVE)
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Diaphragm neuro-mechanical efficiency (NME)
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Grasso, Prof
Organizational Affiliation
University of Bari, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Policlinico
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26728475
Citation
Di Mussi R, Spadaro S, Mirabella L, Volta CA, Serio G, Staffieri F, Dambrosio M, Cinnella G, Bruno F, Grasso S. Impact of prolonged assisted ventilation on diaphragmatic efficiency: NAVA versus PSV. Crit Care. 2016 Jan 5;20:1. doi: 10.1186/s13054-015-1178-0.
Results Reference
derived

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

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