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

Primary Purpose

Ventilator Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
AnapnoGuard 100,
routine mechanical ventilator
Sponsored by
Hospitech Respiration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring VAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RAMBAM Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AnapnoGuard 100

Control

Arm Description

Respiratory guard system during mechanical ventilation

routine mechanical ventilator

Outcomes

Primary Outcome Measures

VAP occurence

Secondary Outcome Measures

Adverse events occurence

Full Information

First Posted
May 15, 2010
Last Updated
February 17, 2016
Sponsor
Hospitech Respiration
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1. Study Identification

Unique Protocol Identification Number
NCT01126320
Brief Title
Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System
Official Title
Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospitech Respiration

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
VAP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AnapnoGuard 100
Arm Type
Experimental
Arm Description
Respiratory guard system during mechanical ventilation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
routine mechanical ventilator
Intervention Type
Device
Intervention Name(s)
AnapnoGuard 100,
Intervention Description
Respiratory guard system during mechanical ventilation with routine mechanical ventilator
Intervention Type
Device
Intervention Name(s)
routine mechanical ventilator
Intervention Description
routine mechanical ventilation
Primary Outcome Measure Information:
Title
VAP occurence
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Adverse events occurence
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaron Bar Lavi, Dr.
Organizational Affiliation
RAMBAM Medical Center, Haifa Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAMBAM Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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