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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01150864

Acronym

AirconVAP

Enrollment

190

Registered

2010-06-25

Start date

2010-04-30

Completion date

2017-03-31

Last updated

2017-05-25

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

Conditions

Acute Lung Injury

Keywords

Hot water humidifier, Passive heat and moisture exchangers

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.

Interventions

DEVICEAirway Conditioning

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction of ventilator associated pneumonia	2 years	development of ventilator associated pneumonia after 48 hours of mechanical ventilation

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026