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

Primary Purpose

Acute Lung Injury

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Airway Conditioning
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lung Injury focused on measuring Hot water humidifier, Passive heat and moisture exchangers

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale di Circolo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Passive Humidifier

Active-Passive humidifier

Hot Water Humidifier

Arm Description

The Passive Humidifier (HME)will changed every 24 hours

The Active-Passive Humidifier will be changed every 24 hours

Hot water humidifier will be set at 36-37 °C

Outcomes

Primary Outcome Measures

Reduction of ventilator associated pneumonia
development of ventilator associated pneumonia after 48 hours of mechanical ventilation

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2010
Last Updated
May 23, 2017
Sponsor
Università degli Studi dell'Insubria
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1. Study Identification

Unique Protocol Identification Number
NCT01150864
Brief Title
Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
Acronym
AirconVAP
Official Title
Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Hot water humidifier, Passive heat and moisture exchangers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Humidifier
Arm Type
Active Comparator
Arm Description
The Passive Humidifier (HME)will changed every 24 hours
Arm Title
Active-Passive humidifier
Arm Type
Active Comparator
Arm Description
The Active-Passive Humidifier will be changed every 24 hours
Arm Title
Hot Water Humidifier
Arm Type
Active Comparator
Arm Description
Hot water humidifier will be set at 36-37 °C
Intervention Type
Device
Intervention Name(s)
Airway Conditioning
Other Intervention Name(s)
Passive: Hygrobac, Active-Passive: Hygrovent Gold, Hot Water: Tyco HC 2000 heated wire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of ventilator associated pneumonia
Description
development of ventilator associated pneumonia after 48 hours of mechanical ventilation
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Endotracheal tube obstruction
Description
difficulties to introduce the airway suction catheter and or need to change the tracheal tube
Time Frame
2 years
Title
nurses' workload
Description
time spent at the bedside by nurses to clear airway's secretions and or to remove water condense from ventilatory circuit
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, MD
Organizational Affiliation
Universita' degli Studi dell'Insubria, Varese, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paolo Severgnini, MD
Organizational Affiliation
University of Insubria, Varese, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale di Circolo
City
Varese
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

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

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