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

Acute Lung Injury Clinical Trial

— AirconVAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150864
• Other study ID #: 0001069
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: May 23, 2017
• Start date: April 2010
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Distress Syndrome, Adult

Intervention

Device:
• Airway 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.

Locations

Country	Name	City	State
Italy	Ospedale di Circolo	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of ventilator associated pneumonia	development of ventilator associated pneumonia after 48 hours of mechanical ventilation	2 years
Secondary	Endotracheal tube obstruction	difficulties to introduce the airway suction catheter and or need to change the tracheal tube	2 years
Secondary	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