Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System

Ventilator Associated Pneumonia Clinical Trial

Official title:

Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126320
• Other study ID #: HST -AG -02
• Status: Completed
• Phase: N/A
• First received: May 15, 2010
• Last updated: February 17, 2016
• Start date: December 2010
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Hospitech Respiration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Ventilator Associated Pneumonia (VAP) is a common complication experienced by mechanically ventilated patients and within the framework of Respiratory Intensive Care Units. The AnapnoGuard system, developed by Hospitech Respiration Ltd. is a ventilation guard system that includes a number of unique characteristics. This study was designed to test the frequency VAP in mechanically ventilated ICU patients using the AnapnoGuard System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ICU patients;

• Patient was connected to AnapnoGuard system up to six hours from intubation;

• Age - above 18.

Exclusion Criteria:

• Pneumonia;

• Aspiration Pneumonia;

• Chronic or Severe Pneumonia;

• Chronic Obstructive Pulmonary Disease (COPD) requiring permanent home-based antibiotic treatment;

• Interstitial Lung Disease (ILD);

• Post Lung Transplant State;

• Immunosuppression.

• Patients ventilated in prone position

• Patient who was ventilated 3 months prior to being enrolled in the study

• Pregnant women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Device:
• AnapnoGuard 100,
Respiratory guard system during mechanical ventilation with routine mechanical ventilator
• routine mechanical ventilator
routine mechanical ventilation

Locations

Country	Name	City	State
Israel	RAMBAM Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Hospitech Respiration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAP occurence		2 years	No
Secondary	Adverse events occurence		2 years	Yes