We hypothesize that nebulisation of ipratropiumbromide results in decreased production of sputum resulting in a better lung aeration (defined by an increase in EELV) and improved oxygenation (as defined by the PaO2/FiO2 ratio and the oxygenation…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the differences in PaO2/FiO2 and oxygenation index.
Secondary outcome
To study the differences in EELV.
Background summary
Ipratropiumbromide (Atrovent®) is an ammonium-containing muscarinic antagonist
(i.e. an anticholinergic agent) that conceptually may decrease sputum
production with resulting increase in lung volume defined by end-expiratory
lung volume (EELV) and improved oxygenation. However, its efficacy on these
outcomes is unclear that warrants further study to rationalise this supportive
treatment.
Study objective
We hypothesize that nebulisation of ipratropiumbromide results in decreased
production of sputum resulting in a better lung aeration (defined by an
increase in EELV) and improved oxygenation (as defined by the PaO2/FiO2 ratio
and the oxygenation index) compared with nebulisation of hypertonic or isotonic
saline in a heterogeneous group of mechanically ventilated critically ill
children. The objective of this study is to test this hypothesis.
Study design
The study is designed as a prospective, randomized interventional pilot study
in the period January 2010 - June 2010.
Intervention
Patients will be randomized to either nebulisation of ipratropiumbromide (if
age less than 4 years 125 micrograms, if age > 4 years then 250 micrograms)
four times a day, endotracheal nebulisation of hypertonic saline (NaCl 3.0%) 4
ml 4 times a day, or to endotracheal nebulisation of isotonic saline (NaCl
0.9%) 4 ml 4 times a day.
Study burden and risks
Patients have to be disconnected from the ventilator once so that the nebuliser
can be placed into the patient circuit. The risks associated with nebulisation
of ipratropiumbromide or saline are minimal, the nurses are well-trained to
perform these procedures.
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
a) pressure-controlled mechanical ventilation for at least 48 hours
b) pulmonary disease present at or acquired during the first 48 hours of PICU admission (i.e. infection, inflammation, trauma, atelectasis)
c) endotracheal tube leakage < 5% (as measured by the mechanical ventilator)
d) informed consent obtained from parents or legal caretakers
e) presence of indwelling arterial catheter
Exclusion criteria
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 or respiratory unstable
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 |
|---|---|
| EudraCT | EUCTR2009-015276-10-NL |
| CCMO | NL29431.042.09 |