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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01150864
Other study ID # 0001069
Secondary ID
Status Completed
Phase N/A
First received May 24, 2010
Last updated May 23, 2017
Start date April 2010
Est. completion date March 2017

Study information

Verified date May 2017
Source Università degli Studi dell'Insubria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date March 2017
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Ospedale di Circolo Varese

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of ventilator associated pneumonia development of ventilator associated pneumonia after 48 hours of mechanical ventilation 2 years
Secondary Endotracheal tube obstruction difficulties to introduce the airway suction catheter and or need to change the tracheal tube 2 years
Secondary nurses' workload time spent at the bedside by nurses to clear airway's secretions and or to remove water condense from ventilatory circuit 2 years
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