Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial

Study Overview
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Brief Summary
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The main hypothesis are: Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices

Detailed Description
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For all Three lines of the study we record Clinical Pulmonary Infection score and Airways Care Score, SOFA (Sequential Organ Failure Assessment), sedation strategy, Glasgow Coma Score and clinical data.

Official Title
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Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial

Conditions
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Acute Lung Injury

Intervention / Treatment
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* Device: Airway Conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients mechanically ventilated with PaO2/FiO2 lower than 300 Age higher than 18 years Invasive mechanical ventilation Endotracheal intubation or tracheostomy for more than 24 hours Exclusion Criteria: Non invasive ventilation Severe ARDS (PaO2/FiO2 lower than 100, or PaCO2 higher than 60 mmHg) Inefficient cough Head Trauma Spinal cervical trauma Chest trauma Pregnancy Expectance of poor survival within 72 hours Congenital airway disease Immunosuppression Supraglottic aspiration devices

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Passive Humidifier<br>The Passive Humidifier (HME)will changed every 24 hours | Device: Airway Conditioning<br>* Each Passive device will be changed daily. When using Active and Passive devices as well as Active-Passive devices the ventilatory circuit will be changed every 7 days.<br>* Other names: Hot Water: Tyco HC 2000 heated wire;|
| Active Comparator: Active-Passive humidifier<br>The Active-Passive Humidifier will be changed every 24 hours | Device: Airway Conditioning<br>* Each Passive device will be changed daily. When using Active and Passive devices as well as Active-Passive devices the ventilatory circuit will be changed every 7 days.<br>* Other names: Hot Water: Tyco HC 2000 heated wire;|
| Active Comparator: Hot Water Humidifier<br>Hot water humidifier will be set at 36-37 °C | Device: Airway Conditioning<br>* Each Passive device will be changed daily. When using Active and Passive devices as well as Active-Passive devices the ventilatory circuit will be changed every 7 days.<br>* Other names: Hot Water: Tyco HC 2000 heated wire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of ventilator associated pneumonia | development of ventilator associated pneumonia after 48 hours of mechanical ventilation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal tube obstruction | difficulties to introduce the airway suction catheter and or need to change the tracheal tube | 2 years | 
| nurses' workload | time spent at the bedside by nurses to clear airway's secretions and or to remove water condense from ventilatory circuit | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot water humidifier, Passive heat and moisture exchangers