Ventilator-associated PneumoniaREINANCT02060045
Prevention Ventilator Associated Pneumonia
A study testing Bundle implementation in people with Ventilator-associated Pneumonia, run by Maria Jesus Perez at 1 site in Spain.
Trial summary
The objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing VAP in a major heart surgery ICU. The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and… 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?
- Bundle implementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,534 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2009to Jun 2012
- 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
- all patients with heart surgery admitted in critical care unit during the study period
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hopsital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
About this study
Official title: Impact of 4 Sequential Measures on the Prevention of Ventilator Associated Pneumonia in Major Heart Surgery Intensive Care Unit
The objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing VAP in a major heart surgery ICU. The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- Bundle implementation
- Keywords
- bundle, prevention, Disturbance; Heart, Functional, Postoperative, Cardiac Surgery
- 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.
Bundle implementationOther
| Study group | Role | What they receive |
|---|---|---|
| bundle implementation | Experimental | The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine. Receives: Other: Bundle implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP)
Change (reduction) in the incidence density of VAP
Measured: Baseline and up to 35 months
Secondary outcomes (5)
Change(length) in Intensive Care Unit (ICU) stay
Measured: Baseline and up to 35 months
Change (number of days) in Mechanical Ventilator (MV) per ICU stay
Measured: Baseline and up to 35 months
Change in mortality rate
Measured: Baseline and up to 35 months
Change in cost of antimicrobial acquisition during ICU stay
Measured: Baseline and up to 35 months
Change in compliance with the measures
Measured: Baseline and up to 35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startNov 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Jesus Perez
- Sponsor type
- University, hospital or other
- Collaborators
- Ciber de Enfermedades Respiratorias, Fundación Rafael del Pino, Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor-investigator, Maria Jesus Perez, Hospital General Universitario Gregorio Marañon
- Investigators
- Maria Jesus Perez, RN, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060045
- Sponsor's protocol ID
- REINA
- Acronym
- REINA
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Bouza E. Impact of four sequential measures on the prevention of ventilator-associated pneumonia in cardiac surgery patients. Crit Care. 2014 Mar 26;18(2):R53. doi: 10.1186/cc13799.
PubMed 24667011
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 4 Sequential Measures on the Prevention of Ventilator Associated Pneumonia in Major Heart Surgery Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02060045
- Acronym / sponsor ID
- REINA / REINA
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- bundle, prevention, Disturbance; Heart, Functional, Postoperative, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,534 participants (actual)
- Lead sponsor
- Maria Jesus PerezUniversity, hospital or other
- Collaborators
- Ciber de Enfermedades Respiratorias, Fundación Rafael del Pino, Fondo de Investigacion Sanitaria
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Feb 2014 (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 objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing VAP in a major heart surgery ICU. The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bundle implementation | Experimental | Other: Bundle implementationThe measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with heart surgery admitted in critical care unit during the study period
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Bundle implementation | Other | bundle implementation |
Primary outcome
Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP)
Time frame: Baseline and up to 35 months
Change (reduction) in the incidence density of VAP
5 secondary outcomes
Change(length) in Intensive Care Unit (ICU) stay
Time frame: Baseline and up to 35 months
Change (number of days) in Mechanical Ventilator (MV) per ICU stay
Time frame: Baseline and up to 35 months
Change in mortality rate
Time frame: Baseline and up to 35 months
Change in cost of antimicrobial acquisition during ICU stay
Time frame: Baseline and up to 35 months
Change in compliance with the measures
Time frame: Baseline and up to 35 months
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 11 Feb 2014.
- Derived from this study: PubMed 24667011Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Bouza E. Impact of four sequential measures on the prevention of ventilator-associated pneumonia in cardiac surgery patients. Crit Care. 2014 Mar 26;18(2):R53. doi: 10.1186/cc13799.
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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.
Maria Jesus Perez, RN principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundle implementation in people with Ventilator-associated Pneumonia, run by Maria Jesus Perez at 1 site in Spain.
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: finished, as of the sponsor's last update on 11 Feb 2014. 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 Spain. 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?
Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP) (time frame: Baseline and up to 35 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060045, which also lists 1 linked publication.
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 11 Feb 2014.