Clinical Trials Directory

Trials / Completed

CompletedNCT02473172

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
38 (actual)
Sponsor
University of Bari · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEPressure Support ventilationAssisted mechanical ventilation
DEVICENeurally Adjusted Ventilatory AssistAssisted mechanical ventilation

Timeline

Start date
2013-05-01
Primary completion
2014-05-01
Completion
2015-05-01
First posted
2015-06-16
Last updated
2015-06-16

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02473172. Inclusion in this directory is not an endorsement.