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Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators During Mechanical Ventilation (Nebulae)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02159196
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.


Condition or disease Intervention/treatment Phase
Respiratory Failure Drug: acetylcysteine and salbutamol Drug: acetylcysteine Drug: salbutamol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
Other Names:
  • 3 mL fluimucil 100mg/ml
  • 2.5 mL ventolin 2.5 Nebules 2.5mg/2.5 ml

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.

Drug: acetylcysteine
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)

Drug: salbutamol
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: day 28 and day 90 after ICU admission and intubation ]
    length of stay (ICU and hospital)

  2. Mortality [ Time Frame: day 28 and day 90 after ICU admission and intubation ]
    ICU and hospital mortality

  3. 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;

  4. 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);


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Netherlands
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
Isala
Zwolle, Overijssel, Netherlands, 8025BT
Sint Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3430 EM
Rijnstate Ziekenhuis
Arnhem, Netherlands, 6815 AD
MC Haaglanden
Den Haag, Netherlands, 2512 VA
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Marcus J Schultz, Prof Dr MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02159196    
Other Study ID Numbers: Nebulae
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
mechanical ventilation
nebulisation
respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Acetylcysteine
Albuterol
Expectorants
Bronchodilator Agents
Pharmaceutical Solutions
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents