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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2010

Last Updated Date

June 24, 2010

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01150864 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The main hypothesis are:

Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia
Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction
Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Acute Lung Injury

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Passive Humidifier
The Passive Humidifier (HME)will changed every 24 hours

Intervention: Device: Airway Conditioning
Active Comparator: Active-Passive humidifier
The Active-Passive Humidifier will be changed every 24 hours

Intervention: Device: Airway Conditioning
Active Comparator: Hot Water Humidifier
Hot water humidifier will be set at 36-37 °C

Intervention: Device: Airway Conditioning

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

190

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Paolo Severgnini, MD

0039-0332-278801

paolo.severgnini@uninsubria.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01150864

Other Study ID Numbers ^ICMJE

0001069

Has Data Monitoring Committee

Responsible Party

Malesci Anna, Ospedale di Circolo, Varese, Italy

Study Sponsor ^ICMJE

Università degli Studi dell'Insubria

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Università degli Studi dell'Insubria

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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