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OpenTrials
Completed

NCT Number: NCT01150864

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

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

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Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale di Circolo

Varese, 21100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airway Conditioning

Device

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

Primary outcomes

  1. Reduction of ventilator associated pneumonia

    Time frame: 2 years

    development of ventilator associated pneumonia after 48 hours of mechanical ventilation

Secondary outcomes

  1. Endotracheal tube obstruction

    Time frame: 2 years

    difficulties to introduce the airway suction catheter and or need to change the tracheal tube

  2. 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

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Acronym: AirconVAP

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Jun 25, 2010
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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