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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Hospitech Respiration
Sponsor:
Information provided by (Responsible Party):
Hospitech Respiration
ClinicalTrials.gov Identifier:
NCT01126320
First received: May 15, 2010
Last updated: May 20, 2014
Last verified: May 2014
  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:


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 2015
Estimated Primary Completion Date: December 2014 (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
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 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: May 20, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Hospitech Respiration:
VAP

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

ClinicalTrials.gov processed this record on October 20, 2014