Effectiveness of routine nebulisation of mucolytic agents and bronchodilating drugs in intubated and ventilated intensive care unit patients.

Completed

Conditions: lung failure
Respiratory insufficiency
10004018
10024967

Registration Number: NL-OMON41284

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 950

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical endpoint is the number of ventilator-free days, defined as<br /><br>the number of days from day 1 to day 28 after ICU admission and start of<br /><br>ventilation, on which a patient breathes without assistance of the ventilator,<br /><br>if the period of unassisted breathing lasted at least 24 consecutive hours.<br /><br>Patients who die or are mechanically ventilated longer than this period are<br /><br>assigned zero ventilator-free days.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary clinical endpoints are: (a) ICU lenght of stay (b) hospital length of<br /><br>stay (c) ICU mortality (d) hospital mortality, (e) incidence of secondary ARDS<br /><br>using consensus criteria (d) ventilator-associated pneumonia (e) atelectases<br /><br>(f) any side effect of nebulisation of mucolytics and bronchodilatators or the<br /><br>nebulisation itself<br /><br><br /><br>In addition, related health care costs will be estimated from a health system<br /><br>perspective including costs of (a) ventilation and (b) stay in ICU and/or<br /><br>hospital; (c) costs of cumulative use of sedatives and neuromuscular blocking<br /><br>agents, (f) the use of tracheostomies (g)<br /><br>ventilator-associated pneumonia.</p><br>