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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Università degli Studi dell'Insubria.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01150864
First received: May 24, 2010
Last updated: June 24, 2010
Last verified: May 2010
  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 Phase
Acute Lung Injury
Device: Airway Conditioning
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Università degli Studi dell'Insubria:

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


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

  • nurses' workload [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    time spent at the bedside by nurses to clear airway's secretions and or to remove water condense from ventilatory circuit


Estimated Enrollment: 190
Study Start Date: April 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150864

Contacts
Contact: Paolo Severgnini, MD 0039-0332-278801 paolo.severgnini@uninsubria.it

Locations
Italy
Ospedale di Circolo Recruiting
Varese, Italy, 21100
Contact: Paolo Severgnini, MD    0039-0332-278801    paolo.severgnini@uninsubria.it   
Principal Investigator: Paolo Severgnini, MD         
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

No publications provided

Responsible Party: Malesci Anna, Ospedale di Circolo, Varese, Italy
ClinicalTrials.gov Identifier: NCT01150864     History of Changes
Other Study ID Numbers: 0001069
Study First Received: May 24, 2010
Last Updated: June 24, 2010
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 20, 2014