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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01150864
First Posted: June 25, 2010
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria
  Purpose

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

Condition Intervention
Acute Lung Injury Device: Airway Conditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Paolo Severgnini, Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • Reduction of ventilator associated pneumonia [ Time Frame: 2 years ]
    development of ventilator associated pneumonia after 48 hours of mechanical ventilation


Secondary Outcome Measures:
  • Endotracheal tube obstruction [ Time Frame: 2 years ]
    difficulties to introduce the airway suction catheter and or need to change the tracheal tube

  • 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


Enrollment: 190
Study Start Date: April 2010
Study Completion Date: March 2017
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150864


Locations
Italy
Ospedale di Circolo
Varese, Italy, 21100
Sponsors and Collaborators
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
  More Information

Responsible Party: Paolo Severgnini, MD, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01150864     History of Changes
Other Study ID Numbers: 0001069
First Submitted: May 24, 2010
First Posted: June 25, 2010
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by Paolo Severgnini, Università degli Studi dell'Insubria:
Hot water humidifier, Passive heat and moisture exchangers

Additional relevant MeSH terms:
Pneumonia
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Thoracic Injuries
Wounds and Injuries
Respiration Disorders
Cross Infection
Infection
Ventilator-Induced Lung Injury