Frequency of Ventilator Associated Pneumonia (VAP) in Mec... | NCT01126320

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

NCT01126320

Sponsor

Hospitech Respiration

Status

Completed

Last Update Posted

Feb 19, 2016Estimated

Enrollment

161Actual

Phase

Not Applicable

Conditions

Ventilator Associated Pneumonia

Interventions

AnapnoGuard 100,
routine mechanical ventilator

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jul 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

May 15, 2010

First Submission Date that Met QC Criteria

May 18, 2010

First Posted Date

May 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2016

Last Update Posted Date

Feb 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AnapnoGuard 100	Experimental	Respiratory guard system during mechanical ventilation	Device: AnapnoGuard 100,
Control	Active Comparator	routine mechanical ventilator	Device: routine mechanical ventilator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AnapnoGuard 100,	Device	Respiratory guard system during mechanical ventilation with routine mechanical ventilator	AnapnoGuard 100

Measure	Description	Time Frame
VAP occurence		2 years

Measure	Description	Time Frame
Adverse events occurence		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yaron Bar Lavi, Dr.	RAMBAM Medical Center, Haifa Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RAMBAM Medical Center		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided