To compare the tidal volume distribution and other ventilator parameters between PAV+ and NAVA.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are a shift of tidal impedance variation from the
ventral and central area of the lung towards central and dorsal area of the
lung, and stable PAV+ ventilation for 2-3 days.
Secondary outcome
The secondary objective is to assess the applicability of PAV+ in our current
ICU population.
Background summary
Proportional Assist Ventilation with load-adjusted gain factors (PAV+) is a new
ventilation mode that delivers pressure proportional to the effort of the
patient by measuring the resistance and compliance of the respiratory system
trough the airway. It differs from Neurally Adjusted Ventilatory Assist (NAVA),
another proportional mode, in that it is non-invasive. It is hypothesized that
PAV+ will have similar effects on the tidal ventilation distribution than NAVA
by promoting dorsal ventilation. This has not yet been objectified.
Study objective
To compare the tidal volume distribution and other ventilator parameters
between PAV+ and NAVA.
Study design
Randomized intervention pilot study.
Intervention
Subjects are ventilated for 2-3 days with either NAVA (Group I) or PAV+ (Group
II). Thereafter, the subject is ventilated using three levels of NAVA and three
levels of PAV+ for 10 minutes each while more extensive respiratory mechanics
measurements are performed.
Study burden and risks
The risk of this study is considered negligible. The burden for each a subject
is considered mild. The benefit for the ICU population - i.e. a better insight
in the physiology during PAV+ ventilation and a step towards non-invasive
assist ventilation - is considered sufficient to justify the burden to the
subjects.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Subject received mechanical ventilation with the Pressure Support mode and/or Neurally Adjusted Ventilatory Assist mode for at least 16 hours.
Exclusion criteria
Hemodynamic instability, respiratory distress during mechanical ventilation at inclusion, lack of spontaneous breathing effort.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54587.078.15 |