NCT02473172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

June 8, 2015

Last Update Submit

June 11, 2015

Conditions

Respiratory Insufficiency

Keywords

Weaning from mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours

Secondary Outcomes (1)

  • Diaphragm neuro-mechanical efficiency (NME)

    48 hours

Study Arms (2)

Pressure Support Ventilation

EXPERIMENTAL

Assisted mechanical ventilation

Device: Pressure Support ventilation

Neurally Adjusted Ventilatory Assist

EXPERIMENTAL

Assisted mechanical ventilation

Device: Neurally Adjusted Ventilatory Assist

Interventions

Pressure Support ventilationDEVICE

Assisted mechanical ventilation

Pressure Support Ventilation
Neurally Adjusted Ventilatory AssistDEVICE

Assisted mechanical ventilation

Neurally Adjusted Ventilatory Assist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico

Bari, 70124, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26728475DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Salvatore Grasso, Prof

    University of Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 16, 2015

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

IT(1)