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

May 23, 2017 updated by: Paolo Severgnini, Università degli Studi dell'Insubria

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy, 21100
        • Ospedale Di Circolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Passive Humidifier
The Passive Humidifier (HME)will changed every 24 hours
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.
Other Names:
  • Passive: Hygrobac
  • Active-Passive: Hygrovent Gold
  • Hot Water: Tyco HC 2000 heated wire
Active Comparator: Active-Passive humidifier
The Active-Passive Humidifier will be changed every 24 hours
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.
Other Names:
  • Passive: Hygrobac
  • Active-Passive: Hygrovent Gold
  • Hot Water: Tyco HC 2000 heated wire
Active Comparator: Hot Water Humidifier
Hot water humidifier will be set at 36-37 °C
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.
Other Names:
  • Passive: Hygrobac
  • Active-Passive: Hygrovent Gold
  • Hot Water: Tyco HC 2000 heated wire

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Study Director: Paolo Pelosi, MD, Universita' degli Studi dell'Insubria, Varese, Italy
  • Principal Investigator: Paolo Severgnini, MD, University of Insubria, Varese, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 25, 2010

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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