Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators in Mechanically Ventilated Intensive Care Patients' (Nebulae)

NCT02159196 NA COMPLETED

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.

Details

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	NA
Status	COMPLETED
Enrolment	950
Start date	2014-07
Completion	2017-06

Conditions

• Respiratory Failure

Interventions

• acetylcysteine and salbutamol
• acetylcysteine
• salbutamol

Primary outcomes

• Number of ventilator-free days at day 28 — day 28 after ICU admission and intubation
  The number of ventilator-free days (VFDs) is defined as the number of days from day 1 to day 28 after ICU admission and start of mechanical 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.

Countries

Netherlands