Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators During Mechanical Ventilation (Nebulae)
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|ClinicalTrials.gov Identifier: NCT02159196|
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : June 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure||Drug: acetylcysteine and salbutamol Drug: acetylcysteine Drug: salbutamol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||950 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators in Mechanically Ventilated Intensive Care Patients'|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||June 2017|
Active Comparator: acetylcysteine and salbutamol
Nebulisation of 3 mL-solution of acetylcysteine (fluimucil 100mg/ml, a mucolytic) and a 2.5 mL solution containing salbutamol (ventolin 2.5 Nebules 2.5mg/2.5 ml, a bronchodilator), administered every 6 hours (i.e., 4 times per day) within 24 hours after initiation of ventilation until tracheal extubation.
Drug: acetylcysteine and salbutamol
routine nebulisation of a 3 mL-solution of acetylcysteine (fluimucil 100mg/ml) and a 2.5 mL solution containing salbutamol (ventolin 2.5 Nebules 2.5mg/2.5 ml) four times daily
Experimental: acetylcysteine or salbutamol
Nebulisation on strict clinical indications; nebulisation of 3 mL-solution of acetylcysteine (fluimucil 100mg/ml, a mucolytic) in case of occurrence of persistent thick and tenacious sputum and only after active humidification is set.
Nebulisation of 2.5 mL solution containing salbutamol (ventolin 2.5 Nebules 2.5mg/2.5 ml, a bronchodilator) in case of occurrence of bronchospasm.
nebulisation of acetylcysteine on strict clinical indications only', i.e. in case of occurrence of persistent thick and tenacious sputum
Other Name: 3 mL-solution of acetylcysteine (fluimucil 100mg/ml)
nebulisation of salbutamol on strict clinical indications only', i.e. in case of occurrence of bronchospasm
Other Name: 2.5 mL salbutamol (ventolin 2.5 Nebules 2.5mg/2.5 ml
- Number of ventilator-free days at day 28 [ Time Frame: 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.
- Length of stay [ Time Frame: day 28 and day 90 after ICU admission and intubation ]length of stay (ICU and hospital)
- Mortality [ Time Frame: day 28 and day 90 after ICU admission and intubation ]ICU and hospital mortality
- Pulmonary complications [ Time Frame: daily until detubation or day 28 ]Pulmonary complications will include but are not limited to: incidence of Ventilator-associated Pneumonia (VAP); incidence of secondary acute respiratory distress syndrome (ARDS); atelectasis;
- Side effects [ Time Frame: daily until detubation or day 28 ]Side effects of nebulization of mucolytics and/or bronchodilators (due to nebulization itself, or as a result of exposure to the nebulized agents);
- Health care related costs [ Time Frame: until detubation or day 28 ]Health care related costs, including costs of ventilation, stay in ICU and/or hospital, cumulative use of sedative drugs and neuromuscular blocking agents, use of tracheostomies, and costs of ventilator-associated pneumonia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159196
|Amphia Ziekenhuis Breda|
|Breda, Brabant, Netherlands, 4818 CK|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Noord Holland, Netherlands, 1090 HM|
|Academic Medical Center|
|Amsterdam, Noord-Holland, Netherlands, 1105 AZ|
|Zwolle, Overijssel, Netherlands, 8025BT|
|Sint Antonius Ziekenhuis|
|Nieuwegein, Utrecht, Netherlands, 3430 EM|
|Arnhem, Netherlands, 6815 AD|
|Den Haag, Netherlands, 2512 VA|
|Principal Investigator:||Marcus J Schultz, Prof Dr MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|