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Effect of daily nebulisation of a mucolytic and bronchodilation agent in intensive care patients in need for mechanical ventilation because of lungfailure


- candidate number16895
- NTR NumberNTR4465
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2014
- Secondary IDs NL4780701814
- Public TitleEffect of daily nebulisation of a mucolytic and bronchodilation agent in intensive care patients in need for mechanical ventilation because of lungfailure
- Scientific TitleEffectiveness of routine nebulisation of mucolitycs and bronchodilators in mechanically ventilated patients
- ACRONYMNebulae
- hypothesisA strategy restricting nebulisation of mucolytics and bronchodilators to patients with sputum plugging is as effective as, but cheaper and safer than, a strategy using routine nebulisation in all intubated and mechanically ventilated ICU patients.
- Healt Condition(s) or Problem(s) studiedNebulization, Mechanical ventilation, Lungfailure, Bronchodilator, Mucolytic
- Inclusion criteriaAge 18 year or older Expected duration of intubation and ventilation > 24 hour Written informed consent
- Exclusion criteriaVentilation before present ICU admission (though short-term ventilation in the emergency room or in the operation room for general anesthesia during surgery is allowed) Pregnancy Lung disease for which inhalation therapy and/or oral steroids are used Diagnoses of: Guillain-Barré syndrome, complete spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis and myasthenia gravis Allergy for acetylcysteine or salbutamol
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-jun-2016
- Target number of participants950
- InterventionsRoutine nebulisation of mucolytics and bronchodilators administered every 6 hours is compared to nebulisation of mucolytics and bronchodilators on strict clinical indication (i.e., only if a patient shows to have problems with sputum clearance or bronchospasm).
- Primary outcomeNumber of ventilator-free days (VFDs), defined as the number of days from day 1 to day 28 after ICU admission and start of mechanical ventilation
- Secondary outcome-ICU and hospital length of stay -ICU and hospital mortality -secondary ARDS -ventilator-associated pneumonia -atelectasis -side effects of nebulisation of mucolytics and bronchodilators -related health care costs will be estimated with a cost benefit – and budget impact analysis
- TimepointsFrom admission at the ICU and start of ventilation till discharge of the ICU, 90 days follow up telephone call
- Trial web sitehttps://sites.google.com/site/nebulaetrial/home-1
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Sophia Hoeven, van der
- CONTACT for SCIENTIFIC QUERIESProf. dr. Marcus J. Schultz
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryObjective: determine the effect of a strategy using routine nebulisation of mucolytics and bronchodilators (four times daily) as compared to a strategy using nebulisation of mucolytics or bronchodilators only on clinical indication (i.e. occurrence of persistent thick and tenacious sputum or bronchospasm) in mechanically ventilated intensive care patients. Design: investigator initiated multicenter randomized controlled non-inferiority trial in mechanically ventilated intensive care patients. Main endpoints: number of ventilator-free days (VFDs), ICU and hospital length of stay and mortality, incidence of secondary ARDS, ventilator-associated pneumonia, atelectasis and side effects of nebulisation of mucolytics and bronchodilators. Also, related health care costs will be estimated with a cost benefit – and budget impact analysis.
- Main changes (audit trail)
- RECORD17-mrt-2014 - 6-sep-2014


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