The primary objective is to assess the association between the EELV measured with RIP and EIT, and to graphically depict the changes in the pressure volume curve during stepwise decreasing the CDP in a recruited lung and correlate these with…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
End expiratory lung volume (EELV) measured by RIP and EIT.
Secondary outcome
- Tidal volume generated by the oscillator
- Diaphragm activity
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.
With this study we want to test the hypothesis that during HFOV, after
recruitment of the lung, the RIP signal and tidal volume are useful tools to
titrate the lowest optimal CDP with adequate lung volume in pediatric patients
with ARDS
Study objective
The primary objective is to assess the association between the EELV measured
with RIP and EIT, and to graphically depict the changes in the pressure volume
curve during stepwise decreasing the CDP in a recruited lung and correlate
these with clinical estimates of lung recruitment (SpO2 and Pa O2) in order to
predict the closing pressure of the lung, before effective closure occurs.
Study design
Prospective, observational study without invasive measurements.
Study burden and risks
There are a priori no specific benefits for the patients who participate in the
study. We consider the risks associated with this non-therapeutic study
acceptable and the burden minimal, based upon the following arguments:
•Blood sample drawing is done via the already present indwelling arterial line,
so that no additional venous or arterial punctures are necessary.
•All parameters collected in this study are displayed real-time on either the
ventilator or the pulmonary function monitor; only the EIT, RIP and diaphragm
activity analyses are performed off-line.
•For the EIT measurements 16 electrodes must be placed circumferentially around
the chest; Diaphragma activity is measured with three electrodes placed on the
chest; For the RIP measurements two elastic bands are placed circumferentially
around the patient*s chest and abdomen. The electrodes are fully comparable
with the electrodes routinely used for ECG monitoring; hence they pose minimal
burden.
Hanzeplein 1 huispost CA 80
Groningen 9713 GZ
NL
Hanzeplein 1 huispost CA 80
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
*Confirmed diagnosis of peadiatric ARDS orginating from any cause
*Presence of indwelling arterial catheter
*Indication for HFOV identified by the attending physician
*Informed consent obtained from parents or legal caretakers
*Age <12 years
Exclusion criteria
*Weight less than kg
*No indication for HFOV indentified by the attending physician
*Open abdomen or thorax after surgery
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 | NL51184.042.15 |
| Other | UMCG research register 201501145 |