Ventilator-associated PneumoniaPhase 4NCT01546974
Ventilator-associated Pneumonia (VAP) and Humidification System
A Phase 4 study testing HME filter Twin Star 55, Drager Medical, Germany and Heated humidification in people with Ventilator-associated Pneumonia, run by Hospital Sao Domingos at 1 site in Brazil.
Trial summary
The purpose of this study is to determine which humidification system is more effective in preventing pneumonia in mechanically ventilated patients. The study will compare a heat and moisture exchanger versus heated humidification. 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?
- HME filter Twin Star 55, Drager Medical, Germany and Heated humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Feb 2014
- Phase
- Phase 4
- 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
- Patients expected to require mechanical ventilation for at least 48 hours
Who cannot join
- Patients < 18 yo and pregnant
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Sao Domingos
São Luís, Maranhão, 65060-000
JOSE R AZEVEDO, MD
About this study
Official title: Prospective Analysis of the Incidence of Ventilator-associated Pneumonia Related to the Humidification System: Heat and Moisture Exchanger Versus Heated Humidification
The purpose of this study is to determine which humidification system is more effective in preventing pneumonia in mechanically ventilated patients. The study will compare a heat and moisture exchanger versus heated humidification.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- HME filter Twin Star 55, Drager Medical, Germany, Heated humidification
- Keywords
- Mechanical Ventilation, Humidification system, Patients submitted to mechanical ventilation for at least 48 hours
- 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.
HME filter Twin Star 55, Drager Medical, GermanyDevice
Heated humidificationDevice
| Study group | Role | What they receive |
|---|---|---|
| HME filter | Experimental | Not described Receives: Device: HME filter Twin Star 55, Drager Medical, Germany |
| Heated humidificator MR 730 Fisher & Paykel | Experimental | Not described Receives: Device: Heated humidification |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP incidence
Secondary outcomes (1)
Duration of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2013 (estimated)
- Study completionFeb 2014 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOSE R AZEVEDO, MD, Study chair, Director ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546974
- Sponsor's protocol ID
- hsd2012
- Other IDs
- CEP026/2011
- Status last verified
- Jan 2012
- First submitted
- 3 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Incidence of Ventilator-associated Pneumonia Related to the Humidification System: Heat and Moisture Exchanger Versus Heated Humidification
- ClinicalTrials.gov ID
- NCT01546974
- Acronym / sponsor ID
- hsd2012
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- Mechanical Ventilation, Humidification system, Patients submitted to mechanical ventilation for at least 48 hours
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 7 Mar 2012 (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.
The purpose of this study is to determine which humidification system is more effective in preventing pneumonia in mechanically ventilated patients. The study will compare a heat and moisture exchanger versus heated humidification.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HME filter | Experimental | Device: HME filter Twin Star 55, Drager Medical, Germany |
| Heated humidificator MR 730 Fisher & Paykel | Experimental | Device: Heated humidification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients expected to require mechanical ventilation for at least 48 hours
Key exclusion criteria (1 listed)
- Patients < 18 yo and pregnant
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 |
|---|---|---|
| HME filter Twin Star 55, Drager Medical, Germany | Device | HME filter |
| Heated humidification | Device | Heated humidificator MR 730 Fisher & Paykel |
Primary outcome
VAP incidence
1 secondary outcome
Duration of mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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Ventilator-Associated Pneumonia (VAP)
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.
JOSE R AZEVEDO, MD study chair
Director ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HME filter Twin Star 55, Drager Medical, Germany and Heated humidification in people with Ventilator-associated Pneumonia, run by Hospital Sao Domingos at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Mar 2012. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE R AZEVEDO, MD (55 98 32168110, jrazevedo@elo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP incidence. 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 7 Mar 2012.