Ventilator Associated PneumoniaNCT01126320
Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System
A study testing AnapnoGuard 100, and routine mechanical ventilator in people with Ventilator Associated Pneumonia, run by Hospitech Respiration at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- AnapnoGuard 100, and routine mechanical ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients;
- Patient was connected to AnapnoGuard system up to six hours from intubation;
- Age - above 18.
Who cannot join
- 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;
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- Immunosuppression.
- Patients ventilated in prone position
- Patient who was ventilated 3 months prior to being enrolled in the study
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System
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.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- AnapnoGuard 100,, routine mechanical ventilator
- Keywords
- VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnapnoGuard 100,Device
Respiratory guard system during mechanical ventilation with routine mechanical ventilator
routine mechanical ventilatorDevice
routine mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| AnapnoGuard 100 | Experimental | Respiratory guard system during mechanical ventilation Receives: Device: AnapnoGuard 100, |
| Control | Active comparator | routine mechanical ventilator Receives: Device: routine mechanical ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP occurence
Measured: 2 years
Secondary outcomes (1)
Adverse events occurence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitech Respiration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaron Bar Lavi, Dr., Principal investigator, RAMBAM Medical Center, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126320
- Sponsor's protocol ID
- HST -AG -02
- Status last verified
- Feb 2016
- First submitted
- 15 May 2010
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System
- ClinicalTrials.gov ID
- NCT01126320
- Acronym / sponsor ID
- HST -AG -02
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- VAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Hospitech RespirationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AnapnoGuard 100 | Experimental | Device: AnapnoGuard 100,Respiratory guard system during mechanical ventilation |
| Control | Active comparator | Device: routine mechanical ventilatorroutine mechanical ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICU patients;
- Patient was connected to AnapnoGuard system up to six hours from intubation;
- Age - above 18.
Key exclusion criteria (10 listed)
- Pneumonia;
- Aspiration Pneumonia;
- Chronic or Severe Pneumonia;
- Chronic Obstructive Pulmonary Disease (COPD) requiring permanent home-based antibiotic treatment;
- Interstitial Lung Disease (ILD);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnapnoGuard 100,Respiratory guard system during mechanical ventilation with routine mechanical ventilator | Device | AnapnoGuard 100 |
| routine mechanical ventilatorroutine mechanical ventilation | Device | Control |
Primary outcome
VAP occurence
Time frame: 2 years
1 secondary outcome
Adverse events occurence
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Bar Lavi, Dr. principal investigator
RAMBAM Medical Center, Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AnapnoGuard 100, and routine mechanical ventilator in people with Ventilator Associated Pneumonia, run by Hospitech Respiration at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP occurence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.