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

Not Applicable

Completed

• Conditions: Acute Lung Injury
• Interventions: Device: Airway Conditioning

• Registration Number: NCT01150864
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

The main hypothesis are:

1. Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia

2. Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction

3. Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices

Detailed Description

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2015-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active-Passive humidifier	Airway Conditioning	The Active-Passive Humidifier will be changed every 24 hours
Passive Humidifier	Airway Conditioning	The Passive Humidifier (HME)will changed every 24 hours
Hot Water Humidifier	Airway Conditioning	Hot water humidifier will be set at 36-37 °C

Primary Outcome Measures

Name	Time	Method
Reduction of ventilator associated pneumonia	2 years	development of ventilator associated pneumonia after 48 hours of mechanical ventilation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedale di Circolo; 🇮🇹 Varese, Italy