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

This study has been completed.
Information provided by (Responsible Party):
Hospitech Respiration Identifier:
First received: May 15, 2010
Last updated: February 17, 2016
Last verified: February 2016
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.

Condition Intervention
Ventilator Associated Pneumonia Device: AnapnoGuard 100, Device: routine mechanical ventilator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System

Resource links provided by NLM:

Further study details as provided by Hospitech Respiration:

Primary Outcome Measures:
  • VAP occurence [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Adverse events occurence [ Time Frame: 2 years ]

Enrollment: 161
Study Start Date: December 2010
Study Completion Date: December 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AnapnoGuard 100
Respiratory guard system during mechanical ventilation
Device: AnapnoGuard 100,
Respiratory guard system during mechanical ventilation with routine mechanical ventilator
Active Comparator: Control
routine mechanical ventilator
Device: routine mechanical ventilator
routine mechanical ventilation


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01126320

RAMBAM Medical Center
Haifa, Israel
Sponsors and Collaborators
Hospitech Respiration
Principal Investigator: Yaron Bar Lavi, Dr. RAMBAM Medical Center, Haifa Israel
  More Information

Responsible Party: Hospitech Respiration Identifier: NCT01126320     History of Changes
Other Study ID Numbers: HST -AG -02
Study First Received: May 15, 2010
Last Updated: February 17, 2016

Keywords provided by Hospitech Respiration:

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury processed this record on September 21, 2017