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

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ClinicalTrials.gov Identifier: NCT01126320
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia Device: AnapnoGuard 100, Device: routine mechanical ventilator

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
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
Study Start Date : December 2010
Primary Completion Date : July 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126320


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

Responsible Party: Hospitech Respiration
ClinicalTrials.gov Identifier: NCT01126320     History of Changes
Other Study ID Numbers: HST -AG -02
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Hospitech Respiration:
VAP

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury