Ventilator Associated PneumoniaNCT01188122
Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
A study testing AnapnoGuard 100 in people with Ventilator Associated Pneumonia, run by Hospitech Respiration at 1 site in Romania.
Trial summary
Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteRomania
- Study dates
- Apr 2008to Sep 2009
- 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
- Age above 18 (men and woman);
- Patient is admitted to ICU and expected to receive mechanical ventilation for at least 48 hours;
- Normal chest X-ray;
- Connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
- Signed informed consent by subject's legally acceptable representative.
Who cannot join
- Patients who had been treated with mechanical ventilation during the last year;
- Fever from known chest/lung origin;
- Patients with facial, oropharyngeal or neck trauma;
- BMI>35;
- Height < 1.6 m;
- Any chest X-ray pathology during the first 24 hours post intubation;
- More than 7 days hospitalization prior to the intubation. Chest/lung infection.
Trial locations and contacts
1 site in 1 country.
About this study
Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure.
This study was design in order to evaluate the feasibility of using the AnapnoGuard system.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- AnapnoGuard 100
- 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 100Device
Respiratory guard system during mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| AnapnoGuard | Experimental | Not described Receives: Device: AnapnoGuard 100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).
Measured: during intubation (2-14 days)
Secondary outcomes (1)
Adverse events occurrence
Measured: During intubation (2-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitech Respiration
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marian Popescu, Dr., Principal investigator, Spitalu Universitar De Urgenta Elias Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188122
- Sponsor's protocol ID
- HST -AG -01
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
- ClinicalTrials.gov ID
- NCT01188122
- Acronym / sponsor ID
- HST -AG -01
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- VAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospitech RespirationIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Aug 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.
Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure.
This study was design in order to evaluate the feasibility of using the AnapnoGuard system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AnapnoGuard | Experimental | Device: AnapnoGuard 100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 (men and woman);
- Patient is admitted to ICU and expected to receive mechanical ventilation for at least 48 hours;
- Normal chest X-ray;
- Connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
- Signed informed consent by subject's legally acceptable representative.
Key exclusion criteria (7 listed)
- Patients who had been treated with mechanical ventilation during the last year;
- Fever from known chest/lung origin;
- Patients with facial, oropharyngeal or neck trauma;
- BMI>35;
- Height < 1.6 m;
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 100Respiratory guard system during mechanical ventilation | Device | AnapnoGuard |
Primary outcome
Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).
Time frame: during intubation (2-14 days)
1 secondary outcome
Adverse events occurrence
Time frame: During intubation (2-14 days)
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 25 Aug 2010.
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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.
Marian Popescu, Dr. principal investigator
Spitalu Universitar De Urgenta Elias Hospital
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 in people with Ventilator Associated Pneumonia, run by Hospitech Respiration at 1 site in Romania.
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 5 inclusion and 7 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 25 Aug 2010. 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 Romania. 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?
Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU). (time frame: during intubation (2-14 days)). 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 25 Aug 2010.