The rational behind nebulisation of mucolytic agents and bronchodilating drugs in intubated and ventilated intensive care unit (ICU) patients was that these patients were less able to clear their airways through coughing, because they received heavy sedation and frequently also paralysis. Nowadays ICU patients receive very little to no sedation or muscle paralysis, possibly making this time- and money-consuming strategy obsolete.
We hypothesize (a) that a strategy that uses nebulisation only on clinical indication not to be inferior to a strategy using preventive nebulisations with regard to duration of ventilation in ICU patients; (b) that a strategy that uses nebulisation only on clinical indication is cheaper; and (c) that a strategy that uses nebulisation only on clinical indication is associated with lesser side-effects.
To determine the effectiveness, safety and related health care costs of a strategy using preventive nebulisation of mucolytics and bronchodilators as compared to a strategy that uses nebulisation only on clinical indication in intubated and ventilated ICU patients.
Study design and patients
A multicenter randomised controlled non-inferiority trial in 2 x 253 intubated and ventilated ICU patients. Outcomes are the number of ventilator-free days at day 28 (primary outcome), length of stay in ICU and hospital, mortality in ICU and hospital, development of ARDS, pneumonia, and/or atelectasis, side-effects and costs.