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CompletedNCT01126320Updated Feb 19, 2016

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

An interventional study of AnapnoGuard 100, and routine mechanical ventilator in Ventilator Associated Pneumonia, sponsored by Hospitech Respiration. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-19.

Sponsored by Hospitech Respiration · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
161
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • VAP
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 161 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Hospitech Respiration is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
161 participants (actual)

Study arms

  • Experimental
    AnapnoGuard 100

    Respiratory guard system during mechanical ventilation

    Device: AnapnoGuard 100,

  • Active comparator
    Control

    routine mechanical ventilator

    Device: routine mechanical ventilator

Interventions

  • DeviceAnapnoGuard 100,

    Respiratory guard system during mechanical ventilation with routine mechanical ventilator

  • Deviceroutine mechanical ventilator

    routine mechanical ventilation

06

What researchers measure

Primary outcomes

  1. VAP occurence

    Time frame: 2 years

Secondary outcomes

  1. Adverse events occurence

    Time frame: 2 years

07

Study locations

1 site
  • RAMBAM Medical Center
    Haifa, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01126320
Lead sponsor
Hospitech Respiration
Responsible party
Sponsor
First posted
May 19, 2010
Start date
Dec 2010
Primary completion
Jul 2015
Completion
Dec 2015
Last update
Feb 19, 2016

Study contacts

Yaron Bar Lavi, Dr.
principal investigator · RAMBAM Medical Center, Haifa Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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