This observational study is designed to test the hypothesis that the Bicore-IITM technology may act as a useful bedside tool during lung recruitment, as well as a tool in the differentiation between lung overdistension or a worsening of disease…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Pressure-volume curve corresponding with each step in incrementing the
continuous distending pressure
* SpO2 corresponding with each step in incrementing the continuous distending
pressure
* PaO2
Secondary outcome
* the time at which recruitment has stabilized at a given CDP
* discrimination between lung overdistension or worsening of disease (decreased
compliance due to atelectasis)
Background summary
High-frequency oscillatory ventilation (HFOV) is an alternative mode of
ventilation that is frequently used in neonatal and paediatric critical care
when conventional mechanical ventilation fails. Assessment of lung
recruitability during HFOV is difficult and at present guided by subjective
clinical parameters including the SpO2.
Study objective
This observational study is designed to test the hypothesis that the
Bicore-IITM technology may act as a useful bedside tool during lung
recruitment, as well as a tool in the differentiation between lung
overdistension or a worsening of disease during HFOV.
Study design
This study is designed as a prospective, observational study without invasive
measurements of neonates and children admitted to the intensive care unit and
ventilated with the oscillator during the period October 2010 * March 2011. The
study is performed at the Beatrix Children*s Hospital/University Medical Center
Groningen, Groningen, The Netherlands, the VU university medical center,
Amsterdam, The Netherlands, and at the Queen Paola Children*s Hospital,
Antwerp, Belgium.
Study burden and risks
There is no risk associated with this study as this is an observational study
without invasive measurements. Patients are not subjected to care or procedures
other than the usual standard-of-care in the intensive care unit. There are
also no specific benefits for the enrolled patients.
P.O. Box 30.001
9700 RB Groningen
NL
P.O. Box 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
- diagnosis of diffuse alveolar disease originating from any cause
- Weight < 25 kg
- Presence of indwelling arterial catheter
- Informed consent obtained from parents or legal caretakers
Exclusion criteria
- obstructive airway disease
- weight less than 3 and more and 25 kg
Design
Recruitment
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 | NL32761.042.10 |