Effectiveness of routine nebulisation of mucolytic agents and bronchodilating drugs in intubated and ventilated intensive care unit patients.

Effectiveness of routine nebulisation of mucolytic agents and bronchodilating drugs in intubated and ventilated intensive care unit patients. - Nebulae

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41284

Enrollment

950

Registered

2014-05-06

Start date

2014-07-22

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung failure Respiratory insufficiency

Interventions

1. four times daily routine nebulisation of mucolytics and bronchodilators 2 nebulisation of mucolytics and/or nebulisation on clinical indication.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 year or older Eexpected duration of intubation and ventilation > 24 hour Written informed consent

Exclusion criteria

Exclusion criteria: 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) Pregnancy Lung disease 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 and myasthenia gravis Allergy for acetylcysteine or salbutamol

Design outcomes

Primary

Measure	Time frame
The primary clinical endpoint is the number of ventilator-free days, defined as the number of days from day 1 to day 28 after ICU admission and start of 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.	—

Measure

Time frame

The primary clinical endpoint is the number of ventilator-free days, defined as the number of days from day 1 to day 28 after ICU admission and start of 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.

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Secondary

Measure	Time frame
Secondary clinical endpoints are: (a) ICU lenght of stay (b) hospital length of stay (c) ICU mortality (d) hospital mortality, (e) incidence of secondary ARDS using consensus criteria (d) ventilator-associated pneumonia (e) atelectases (f) any side effect of nebulisation of mucolytics and bronchodilatators or the nebulisation itself In addition, related health care costs will be estimated from a health system perspective including costs of (a) ventilation and (b) stay in ICU and/or hospital; (c) costs of cumulative use of sedatives and neuromuscular blocking agents, (f) the use of tracheostomies (g) ventilator-associated pneumonia.	—

Measure

Time frame

Secondary clinical endpoints are: (a) ICU lenght of stay (b) hospital length of stay (c) ICU mortality (d) hospital mortality, (e) incidence of secondary ARDS using consensus criteria (d) ventilator-associated pneumonia (e) atelectases (f) any side effect of nebulisation of mucolytics and bronchodilatators or the nebulisation itself In addition, related health care costs will be estimated from a health system perspective including costs of (a) ventilation and (b) stay in ICU and/or hospital; (c) costs of cumulative use of sedatives and neuromuscular blocking agents, (f) the use of tracheostomies (g) ventilator-associated pneumonia.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)