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ID
Source
Brief title
Health condition
Mechanical ventilation, sputum productgion
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the differences in changes in EELV between mechanically ventilated children after endotracheal suctioning with prior nebulisation of ipratropriumbromide, prior instillation of NaCl 0.9% or nothing.
Secondary outcome
To study the differences in PaO2/FiO2 and oxygenation index between mechanically ventilated children after endotracheal suctioning with prior nebulisation of ipratropriumbromide, prior instillation of NaCl 0.9% or nothing.
Background summary
Rationale:
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.
Objective:
1. To study the differences in changes in EELV between mechanically ventilated children after endotracheal suctioning with prior nebulisation of ipratropriumbromide, prior instillation of NaCl 0.9% or nothing;
2. To study the differences in PaO2/FiO2 and oxygenation index between mechanically ventilated children after endotracheal suctioning with prior nebulisation of ipratropriumbromide, prior instillation of NaCl 0.9% or nothing.
Study design:
The study is designed as a prospective, randomized interventional pilot study in the period September – December 2009.
Study population:
All mechanically ventilated children aged 0 – 18 years old.
Intervention (if applicable):
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 installation of sodium chloride (NaCl 0.9%) 2 – 4 ml or to control group (no intervention at all).
Main study parameters/endpoints:
Primary endpoint includes the difference in changes in EELV measured with EIT. Secondary endpoints include the difference in oxygenation defined by PaO2 ratio and the oxygenation index (OI).
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) in a heterogeneous group of mechanically ventilated critically ill children.
Study design
The study periods lasts 24 hours after inclusion, incorporating 4 time points at which measurements are made.
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 installation of sodium chloride (NaCl 0.9%) 2 – 4 ml or to control group (no intervention at all).
P.O. Box 30.001
M.C.J. Kneyber (UMCG)
Beatrix Children's Hospital/University Medical Center Groningen
P.O. Box 30.001
Groningen 9700 RB
The Netherlands
+31 (0)50-3614147
m.c.j.kneyber@bkk.umcg.nl
P.O. Box 30.001
M.C.J. Kneyber (UMCG)
Beatrix Children's Hospital/University Medical Center Groningen
P.O. Box 30.001
Groningen 9700 RB
The Netherlands
+31 (0)50-3614147
m.c.j.kneyber@bkk.umcg.nl
Inclusion criteria
Children are eligible for inclusion if they meet the following criteria:
1. Pressure-controlled mechanical ventilation for at least 24 hours;
2. Endotracheal tube leakage < 5% (as measured by the mechanical ventilator);
3. Informed consent obtained from parents or legal caretakers.
Exclusion criteria
1. Mechanical ventilation less than 24 hours or children on high-frequency oscillatory ventilation;
2. Endotracheal tube leakage > 5%;
3. Pre-existing pulmonary abnormalities;
4. Pre-existing congenital heart disease with significant left-to-right shunt.
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 |
---|---|
NTR-new | NL1838 |
NTR-old | NTR1948 |
Other | : |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |