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

Università degli Studi dell'Insubria

Status: Completed

Conditions: Acute Lung Injury

Treatments: Device: Airway Conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01150864

0001069

Details and patient eligibility

About

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

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

190 participants in 3 patient groups

Passive Humidifier

Active Comparator group

Description:

The Passive Humidifier (HME)will changed every 24 hours

Treatment:

Device: Airway Conditioning

Active-Passive humidifier

Active Comparator group

Description:

The Active-Passive Humidifier will be changed every 24 hours

Treatment:

Device: Airway Conditioning

Hot Water Humidifier

Active Comparator group

Description:

Hot water humidifier will be set at 36-37 °C

Treatment:

Device: Airway Conditioning