To determine the efficiency, safety and health care costs of a strategy using routine nebulisation of mucolytics and bronchodilators four times daily, with a strategy of nebulisation on a strict clinical indication only, in mechanical ventilated…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary clinical endpoint is the number of ventilator-free days, defined as
the number of days from day 1 to day 28 after ICU admission and start of
ventilation, on which a patient breathes without assistance of the ventilator,
if the period of unassisted breathing lasted at least 24 consecutive hours.
Patients who die or are mechanically ventilated longer than this period are
assigned zero ventilator-free days.
Secondary outcome
Secondary clinical endpoints are: (a) ICU lenght of stay (b) hospital length of
stay (c) ICU mortality (d) hospital mortality, (e) incidence of secondary ARDS
using consensus criteria (d) ventilator-associated pneumonia (e) atelectases
(f) any side effect of nebulisation of mucolytics and bronchodilatators or the
nebulisation itself
In addition, related health care costs will be estimated from a health system
perspective including costs of (a) ventilation and (b) stay in ICU and/or
hospital; (c) costs of cumulative use of sedatives and neuromuscular blocking
agents, (f) the use of tracheostomies (g)
ventilator-associated pneumonia.
Background summary
Nebulisation of mucolytics and bronchodilators is a frequently applied routine
strategy in intubated and mechanically ventilated intensive care unit (ICU)
patients. With the aim of preventing sputum plugging and atelectasis by
diluting pulmonary secretion in sedated paralyzed patients, who are less able
to clear their airways trough coughing. Benefits are unknown and since very
little to no sedation or muscle paralysis is provided during mechanical
ventilation nowadays, questions rise whether this this time- and
money-consuming strategy could be considered obsolete. In addition, side
effects of the nebulisation can occure. There are no randomized controlled
trials looking at the clinical efficiency and economical consequences of
preventive nebulisation of mucolytica and bronchodilators in ventilated
patients.
Study objective
To determine the efficiency, safety and health care costs of a strategy using
routine nebulisation of mucolytics and bronchodilators four times daily, with a
strategy of nebulisation on a strict clinical indication only, in mechanical
ventilated intensive care patients.
Study design
An investigator-intitiated multicenter randomised controlled non-inferiority
trial in intubated and ventilated ICU patients. In seven participating centers
950 patients will be randomised between
1. four times daily routine nebulisation of mucolytics and bronchodilators
2.nebulisation of mucolytics and/or bronchodilators on clinical indication
Intervention
1. four times daily routine nebulisation of mucolytics and bronchodilators
2 nebulisation of mucolytics and/or nebulisation on clinical indication.
Study burden and risks
Risks of routine nebulisation are unknown in mechanical ventilated patients.
Nebulisation of mucolytics is suggested to prevent and/or delay endotracheal
tube occlusion and sputum plugging, by dilute sputum, although no solid
research is available. Nebulisation with acetylcysteine may lead to
bronchospasm and with salbutamol may be associated with tachycardia,
tachyarrhythmia, tremor, agitation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age 18 year or older
Eexpected 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 |
|---|---|
| CCMO | NL47807.018.14 |
| Other | NTR4465, NTC02159196 |