Ventilator Associated PneumoniaNCT03763695
Effectiveness of a VAP Prevention Bundle in the PICU
An observational study of Ventilator Associated Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Measures for the VAP prevention in the PICU and Evaluation of VAP incidence before the protocol introduction
- Type of treatment
- Pill or oral medicine
- How many people
- 242 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 30 Jun 2020
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients admitted to our ICU requiring mechanical ventilation for more than 48 hours
Who may be able to join
- age < 18 years
- patients receiving mechanical ventilation for more than 48 hours
Who cannot join
- no informed consent
- pregnancy
- previous endotracheal antibiotic therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, 00168
Orazio Genovese, MD
About this study
Official title: Effectiveness of a Bundle of Ventilator Associated Pneumonia (VAP) Prevention in the Pediatric Intensive Care Unit (PICU): an Observational Study
This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. The investigators will compare the incidence of VAP in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. VAP bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Measures for the VAP prevention in the PICU, Evaluation of VAP incidence before the protocol introduction
- Keywords
- Pediatric intensive care unit, Oral Hygiene Care, Chlorhexidine, Broncho-alveolar lavage, Pharyngeal swab
- 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.
Measures for the VAP prevention in the PICUOther
Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.
Evaluation of VAP incidence before the protocol introductionOther
evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention
| Study group | Role | What they receive |
|---|---|---|
| Retrospective control group | Patients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017) Receives: Other: Evaluation of VAP incidence before the protocol introduction | |
| Prospective group | Patients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018) Receives: Other: Measures for the VAP prevention in the PICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP incidence
Incidence of VAP in pediatric patients intubated for more than 48 hours
Measured: From 48 hours after intubation to 48 hours after extubation
Secondary outcomes (1)
Prevalence of orotracheal bacterial colonization in ventilated patients
Evaluation of orotracheal bacterial colonization in pediatric patients undergoing mechanical ventilation twice a week
Measured: From 48 hours after intubation to 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ilaria Vitali, Antonio Maria Dell Anna, Leonardo Dassatti, Giuseppe Bello, Giorgio Conti, Antonio D Addona
- Responsible party
- Principal investigator, Orazio Genovese, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giorgio Conti, MD, Study chair, Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763695
- Sponsor's protocol ID
- 1855
- Status last verified
- Dec 2018
- First submitted
- 18 Sep 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Bundle of Ventilator Associated Pneumonia (VAP) Prevention in the Pediatric Intensive Care Unit (PICU): an Observational Study
- ClinicalTrials.gov ID
- NCT03763695
- Acronym / sponsor ID
- 1855
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Pediatric intensive care unit, Oral Hygiene Care, Chlorhexidine, Broncho-alveolar lavage, Pharyngeal swab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Ilaria Vitali, Antonio Maria Dell Anna, Leonardo Dassatti, Giuseppe Bello, Giorgio Conti, Antonio D Addona
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 4 Dec 2018 (actual)
- 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.
This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. The investigators will compare the incidence of VAP in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. VAP bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective control group | – | Other: Evaluation of VAP incidence before the protocol introductionPatients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017) |
| Prospective group | – | Other: Measures for the VAP prevention in the PICUPatients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients admitted to our ICU requiring mechanical ventilation for more than 48 hours
Key inclusion criteria (2 listed)
- age < 18 years
- patients receiving mechanical ventilation for more than 48 hours
Key exclusion criteria (3 listed)
- no informed consent
- pregnancy
- previous endotracheal antibiotic therapy
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 |
|---|---|---|
| Measures for the VAP prevention in the PICUOral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees. | Other | Prospective group |
| Evaluation of VAP incidence before the protocol introductionevaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention | Other | Retrospective control group |
Primary outcome
VAP incidence
Time frame: From 48 hours after intubation to 48 hours after extubation
Incidence of VAP in pediatric patients intubated for more than 48 hours
1 secondary outcome
Prevalence of orotracheal bacterial colonization in ventilated patients
Time frame: From 48 hours after intubation to 48 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Giorgio Conti, MD study chair
Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 inclusion and 3 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 4 Dec 2018. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orazio Genovese, MD (0630153125, orazio.genovese@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP incidence (time frame: From 48 hours after intubation to 48 hours after extubation). 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 4 Dec 2018.