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

Università degli Studi dell'Insubria190 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

190

Conditions

Acute Lung Injury

Interventions

Airway ConditioningDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Ospedale di Circolo

Varese, Italy

Outcomes

Primary Outcomes

Reduction of ventilator associated pneumonia

development of ventilator associated pneumonia after 48 hours of mechanical ventilation

Time frame: 2 years

Secondary Outcomes

Endotracheal tube obstruction

difficulties to introduce the airway suction catheter and or need to change the tracheal tube

Time frame: 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

Time frame: 2 years

Data from ClinicalTrials.gov

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