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

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.

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.

From admission at the ICU and start of ventilation till discharge of the ICU, 90 days follow up telephone call

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).