No registrations found.
ID
Source
Brief title
Health condition
Lung failure
Nebulisation
Mechanical ventilation
Bronchodilator (salbutamol)
Mucolytic (acetylcysteine)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number 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
Background summary
Objective: 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.
Study objective
A 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.
Study design
From admission at the ICU and start of ventilation till discharge of the ICU, 90 days follow up telephone call
Intervention
Routine 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).
Academic Medical Center, University of Amsterdam
Meibergdreef 9, G3-228
Sophia Hoeven, van der
Amsterdam 1105 AZ
The Netherlands
+31-20-5666345
s.m.vanderhoeven@amc.uva.nl
Academic Medical Center, University of Amsterdam
Meibergdreef 9, G3-228
Sophia Hoeven, van der
Amsterdam 1105 AZ
The Netherlands
+31-20-5666345
s.m.vanderhoeven@amc.uva.nl
Inclusion criteria
Age 18 year or older
Expected duration of intubation and ventilation > 24 hour
Written informed consent
Exclusion criteria
Ventilation 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
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 | NL4312 |
| NTR-old | NTR4465 |
| Other | NL4780701814 : |