The effect of nebulisation of ipratropiumbromide on oxygenation and end-expiratory lung volume in mechanically ventilated children - MPMV
- Conditions
- Oxygenation and end-expiratory lung volume in mechanically ventilated chldren
- Registration Number
- EUCTR2009-015276-10-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 0
a) pressure-controlled mechanical ventilation for at least 48 hours
b) endotracheal tube leakage < 5% (as measured by the mechanical ventilator)
c) informed consent obtained from parents or legal caretakers
d) presence of indwelling arterial catheter
e) primary pulmonary disease present or acquired during PICU admission (i.e. infection, trauma, atelectasis
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
a)mechanical ventilation less than 48hours or children on high-frequency oscillatory ventilation
b)endotracheal tube leakage > 5%
c)pre-existing congenital heart disease with significant left-to-right shunt
d)haemodynamically (i.e. progressive need for vaso-active drugs) or respiratory (i.e. high PEEP levels) unstable patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study differences in oxygenation (OI and PaO2/FiO2 ratio);Secondary Objective: To study differences in end-expiratory lung volume;Primary end point(s): Oxygenation
- Secondary Outcome Measures
Name Time Method