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

NCT ID: NCT01150864

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2017-03-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Acute Lung Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Passive Humidifier

The Passive Humidifier (HME)will changed every 24 hours

Group Type ACTIVE_COMPARATOR

Airway Conditioning

Intervention Type 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.

Active-Passive humidifier

The Active-Passive Humidifier will be changed every 24 hours

Group Type ACTIVE_COMPARATOR

Airway Conditioning

Intervention Type 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.

Hot Water Humidifier

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

Group Type ACTIVE_COMPARATOR

Airway Conditioning

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Passive: Hygrobac Active-Passive: Hygrovent Gold Hot Water: Tyco HC 2000 heated wire

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Paolo Severgnini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Pelosi, MD

Role: STUDY_DIRECTOR

Universita' degli Studi dell'Insubria, Varese, Italy

Paolo Severgnini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese, Italy

Locations

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Ospedale di Circolo

Varese, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0001069

Identifier Type: -

Identifier Source: org_study_id

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