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

NCT ID: NCT01126320

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AnapnoGuard 100

Respiratory guard system during mechanical ventilation

Group Type EXPERIMENTAL

AnapnoGuard 100,

Intervention Type DEVICE

Respiratory guard system during mechanical ventilation with routine mechanical ventilator

Control

routine mechanical ventilator

Group Type ACTIVE_COMPARATOR

routine mechanical ventilator

Intervention Type DEVICE

routine mechanical ventilation

Interventions

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AnapnoGuard 100,

Respiratory guard system during mechanical ventilation with routine mechanical ventilator

Intervention Type DEVICE

routine mechanical ventilator

routine mechanical ventilation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitech Respiration

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaron Bar Lavi, Dr.

Role: PRINCIPAL_INVESTIGATOR

RAMBAM Medical Center, Haifa Israel

Locations

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RAMBAM Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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HST -AG -02

Identifier Type: -

Identifier Source: org_study_id

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