NCT01126320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

4.6 years

First QC Date

May 15, 2010

Last Update Submit

February 17, 2016

Conditions

Ventilator Associated Pneumonia

Keywords

VAP

Outcome Measures

Primary Outcomes (1)

  • VAP occurence

    2 years

Secondary Outcomes (1)

  • Adverse events occurence

    2 years

Study Arms (2)

AnapnoGuard 100

EXPERIMENTAL

Respiratory guard system during mechanical ventilation

Device: AnapnoGuard 100,

Control

ACTIVE COMPARATOR

routine mechanical ventilator

Device: routine mechanical ventilator

Interventions

AnapnoGuard 100,DEVICE

Respiratory guard system during mechanical ventilation with routine mechanical ventilator

AnapnoGuard 100
routine mechanical ventilatorDEVICE

routine mechanical ventilation

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patients;
  • Patient was connected to AnapnoGuard system up to six hours from intubation;
  • Age - above 18.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yaron Bar Lavi, Dr.

    RAMBAM Medical Center, Haifa Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2010

First Posted

May 19, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

IL(1)