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Trial record 6 of 806 for:    ventilators
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Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System

This study is currently recruiting participants.
Verified April 2013 by Hospitech Respiration
Sponsor:
Information provided by (Responsible Party):
Hospitech Respiration
ClinicalTrials.gov Identifier:
NCT01126320
First received: May 15, 2010
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Hospitech Respiration:

Primary Outcome Measures:
  • VAP occurence [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events occurence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126320

Contacts
Contact: Adi Rachelson (972)-3-919-1648 adir@hospitech.co.il

Locations
Israel
RAMBAM Medical Center Recruiting
Haifa, Israel
Contact: Adi Rachelson     (972)4-919-1648     adir@hospitech.co.il    
Principal Investigator: Yaron Bar-Levi, Dr.            
Sponsors and Collaborators
Hospitech Respiration
Investigators
Principal Investigator: Yaron Bar Lavi, Dr. RAMBAM Medical Center, Haifa Israel
  More Information

No publications provided

Responsible Party: Hospitech Respiration
ClinicalTrials.gov Identifier: NCT01126320     History of Changes
Other Study ID Numbers: HST -AG -02
Study First Received: May 15, 2010
Last Updated: April 29, 2013
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on June 18, 2013