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Mucus in paediatric mechanical ventilation.


- candidate number6306
- NTR NumberNTR1948
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-aug-2009
- Secondary IDs 
- Public TitleMucus in paediatric mechanical ventilation.
- Scientific TitleThe effect of nebulisation of ipratropiumbromide on end-expiratory lung volume and oxygenation in mechanically ventilated children: a pilot study.
- ACRONYMN/A
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedMechanical ventilation, Sputum production
- Inclusion criteriaChildren 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate31-dec-2009
- Target number of participants45
- InterventionsPatients 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).
- Primary outcomeTo 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 outcomeTo 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.
- TimepointsThe study periods lasts 24 hours after inclusion, incorporating 4 time points at which measurements are made.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.C.J. Kneyber (UMCG)
- CONTACT for SCIENTIFIC QUERIESDr. M.C.J. Kneyber (UMCG)
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryRationale:
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).
- Main changes (audit trail)
- RECORD10-aug-2009 - 11-okt-2009


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