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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01126320
Other study ID # HST -AG -02
Secondary ID
Status Completed
Phase N/A
First received May 15, 2010
Last updated February 17, 2016
Start date December 2010
Est. completion date December 2015

Study information

Verified date February 2016
Source Hospitech Respiration
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date December 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Device:
AnapnoGuard 100,
Respiratory guard system during mechanical ventilation with routine mechanical ventilator
routine mechanical ventilator
routine mechanical ventilation

Locations

Country Name City State
Israel RAMBAM Medical Center Haifa

Sponsors (1)

Lead Sponsor Collaborator
Hospitech Respiration

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAP occurence 2 years No
Secondary Adverse events occurence 2 years Yes
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