Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators During Mechanical Ventilation

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this multi-center randomized controlled non-inferiority trial is to 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. The investigators will examine the effects in terms of ventilator-free days, defined as the number of days alive and free of ventilation at day 28 after start of ventilation.

We hypothesize that a strategy that uses nebulisation of mucolytics or bronchodilators only on clinical indication not to be inferior to a strategy using preventive nebulisation of mucolytics or bronchodilators with regard to the number of ventilator free days in ICU patients at day 28.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Acetylcysteine; Albuterol; Bronchodilator Agents; Expectorants; N-monoacetylcystine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Age 18 year or older

• Expected duration of intubation and ventilation > 24 hours

• Written informed consent

Exclusion Criteria:

• Age less than 18 years

• 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)

• Suspected or confirmed pregnancy

• Diagnosed with lung diseases 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, Myasthenia Gravis

• Known allergy for acetylcysteine or salbutamol