NCT01150864

Brief Summary

The main hypothesis are:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

4.9 years

First QC Date

May 24, 2010

Last Update Submit

May 23, 2017

Conditions

Acute Lung Injury

Keywords

Hot water humidifier, Passive heat and moisture exchangers

Outcome Measures

Primary Outcomes (1)

  • Reduction of ventilator associated pneumonia

    development of ventilator associated pneumonia after 48 hours of mechanical ventilation

    2 years

Secondary Outcomes (2)

  • Endotracheal tube obstruction

    2 years

  • nurses' workload

    2 years

Study Arms (3)

Passive Humidifier

ACTIVE COMPARATOR

The Passive Humidifier (HME)will changed every 24 hours

Device: Airway Conditioning

Active-Passive humidifier

ACTIVE COMPARATOR

The Active-Passive Humidifier will be changed every 24 hours

Device: Airway Conditioning

Hot Water Humidifier

ACTIVE COMPARATOR

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

Device: Airway Conditioning

Interventions

Airway ConditioningDEVICE

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.

Also known as: Passive: Hygrobac, Active-Passive: Hygrovent Gold, Hot Water: Tyco HC 2000 heated wire
Active-Passive humidifierHot Water HumidifierPassive Humidifier

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale di Circolo

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Paolo Pelosi, MD

    Universita' degli Studi dell'Insubria, Varese, Italy

    STUDY DIRECTOR

  • Paolo Severgnini, MD

    University of Insubria, Varese, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 24, 2010

First Posted

June 25, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2017

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

IT(1)