Ventilator-Associated PneumoniaVPLUSNCT02244723
Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia
An observational study of Ventilator-Associated Pneumonia, run by Fondation Hôpital Saint-Joseph at 2 sites in 2 countries.
Trial summary
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. 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?
- Lung ultrasound examination
- How many people
- 98 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2013to 1 Sep 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects will be recruited from mechanically-ventilated patients with suspected VAP in ICUs
Who may be able to join
- Mechanical ventilation for at least 48 hours,
- New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and
- A minimum of two of the following clinical criteria:
- Body temperature ≥ 38.5° C (101° F) or < 36° C (97° F)
- White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells
- Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300
- Purulent respiratory secretions
Who cannot join
- Known ongoing pneumonia
- Patient younger than 18 years old
- Mechanical ventilation <48 hours
- Contraindication to bronchoscopy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Rianimazione I, (Dipartement of Anesthesia and Intensive Care Unit) of Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
About this study
Official title: Prospective, Observational Study of Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly improves outcomes, making rapid identification of patients with VAP an important clinical goal.
This application is for support of a prospective, multi-centered study to evaluate the diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could allow for early and reliable diagnosis of bacterial VAP.
Read more
Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung ultrasound alone and in association with the CPIS.
Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural consolidation, irregular B-lines) in VAP.
Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung ultrasound, and unprotected tracheal aspirate (UTA).
Read the detailed description
Patients will be enrolled within 24 hours of the point at which criteria are met for suspected VAP. Upon enrollment, the following variables will be recorded from the online medical record, and a Clinical Pulmonary Infection Score will be calculated.
- Demographics (height, weight, comorbidities)
- Ventilation parameters
- Infectious disease data during present admission (antibiotic history, culture data)
- Biochemical data (WBC count with differential, arterial blood gas)
- Microbiological data (UTA and BAL) - UTA data must have been collected within 24 hours of enrollment and BAL data within 12 hours of enrollment
- Radiological data (CXR or chest CT)
Lung ultrasound will be performed within 24 hours of the point at which criteria are met for suspected VAP. Lung ultrasound will include examination of both lungs. Each hemithorax will be divided into three regions using anterior and posterior axillary lines as landmarks. Each of these regions will be further divided into upper and lower quadrants, yielding a total of 6 quadrants per hemithorax. Examination will specifically identify the presence or absence of the following lung ultrasound findings: normal pleural A lines, non-coalescent B lines, coalescent B lines, consolidations (subpleural or lobar), and linear air bronchograms. A Lung Ultrasound Aeration Score will be calculated based on these findings. Ultrasonographic diagnosis of VAP will be defined based on the presence of subpleural consolidation, entire lobar consolidation, or air bronchogram within consolidation.
The results of microbiological data will be followed up for confirmation of culture results. Cultures will be considered positive if ≥ 100,000 bacterial colony-forming units (cfu) are isolated.
At day #28 of study enrollment, the patient's status will be documented (alive vs. deceased, inpatient vs. discharged).
- Conditions
- Ventilator-Associated Pneumonia
- Being tested
- Lung ultrasound examination
- Keywords
- Ventilator-Associated Pneumonia, diagnosis
- Medical subject headings
- Pneumonia, Ventilator-Associated, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound examinationOther
Lung ultrasound (LUS) is increasingly being used at the bedside for assessing alveolar-interstitial syndrome, lung consolidation, pneumonia, pneumothorax, and pleural effusion. It could be an easily repeatable noninvasive tool for diagnosis of ventilator associated pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected VAP | Only one group is studied : mechanically-ventilated patients with suspected VAP in ICUs.
For each patient a lung ultrasound examination will be performed. Receives: Other: Lung ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-associated pneumonia.
Ventilator associated pneumonia is diagnosed when patient has a positive broncho alveolar lavage (positive cultiure >10*3 CFU/ml) and clinical criteria (◦Body temperature ≥ 38.5° C (101° F) or < 36° C (97° F)
- White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells
- Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300
- Purulent respiratory secretion)
Measured: up to 30days
Secondary outcomes (5)
Duration of stay in ICU
Measured: up to 60 days
Duration of hospital say
Measured: up to 60 days
Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose ventilator-associated pneumonia
Measured: up to 30 days
sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with the CPIS to diagnose ventilator-associated pneumonia
Measured: up to 30 days
sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with unprotected tracheal aspirate to diagnose ventilator-associated pneumonia
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start1 Jun 2013
- Primary completion1 Jan 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bélaid BOUHEMAD, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244723
- Sponsor's protocol ID
- VPLUS
- Acronym
- VPLUS
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2013
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
PubMed 19633538Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
PubMed 20851923Wang G, Ji X, Xu Y, Xiang X. Lung ultrasound: a promising tool to monitor ventilator-associated pneumonia in critically ill patients. Crit Care. 2016 Oct 27;20(1):320. doi: 10.1186/s13054-016-1487-y.
PubMed 27784331Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.
PubMed 26836896
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT02244723
- Acronym / sponsor ID
- VPLUS / VPLUS
- Conditions
- Ventilator-Associated Pneumonia
- Keywords
- Ventilator-Associated Pneumonia, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 19 Sep 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.
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly improves outcomes, making rapid identification of patients with VAP an important clinical goal.
This application is for support of a prospective, multi-centered study to evaluate the diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could allow for early and reliable diagnosis of bacterial VAP.
Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung ultrasound alone and in association with the CPIS.
Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural consolidation, irregular B-lines) in VAP.
Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung ultrasound, and unprotected tracheal aspirate (UTA).
Detailed description
Patients will be enrolled within 24 hours of the point at which criteria are met for suspected VAP. Upon enrollment, the following variables will be recorded from the online medical record, and a Clinical Pulmonary Infection Score will be calculated.
- Demographics (height, weight, comorbidities)
- Ventilation parameters
- Infectious disease data during present admission (antibiotic history, culture data)
- Biochemical data (WBC count with differential, arterial blood gas)
- Microbiological data (UTA and BAL) - UTA data must have been collected within 24 hours of enrollment and BAL data within 12 hours of enrollment
- Radiological data (CXR or chest CT)
Lung ultrasound will be performed within 24 hours of the point at which criteria are met for suspected VAP. Lung ultrasound will include examination of both lungs. Each hemithorax will be divided into three regions using anterior and posterior axillary lines as landmarks. Each of these regions will be further divided into upper and lower quadrants, yielding a total of 6 quadrants per hemithorax. Examination will specifically identify the presence or absence of the following lung ultrasound findings: normal pleural A lines, non-coalescent B lines, coalescent B lines, consolidations (subpleural or lobar), and linear air bronchograms. A Lung Ultrasound Aeration Score will be calculated based on these findings. Ultrasonographic diagnosis of VAP will be defined based on the presence of subpleural consolidation, entire lobar consolidation, or air bronchogram within consolidation.
The results of microbiological data will be followed up for confirmation of culture results. Cultures will be considered positive if ≥ 100,000 bacterial colony-forming units (cfu) are isolated.
At day #28 of study enrollment, the patient's status will be documented (alive vs. deceased, inpatient vs. discharged).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected VAP | – | Other: Lung ultrasound examinationOnly one group is studied : mechanically-ventilated patients with suspected VAP in ICUs. For each patient a lung ultrasound examination will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects will be recruited from mechanically-ventilated patients with suspected VAP in ICUs
Key inclusion criteria (7 listed)
- Mechanical ventilation for at least 48 hours,
- New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and
- A minimum of two of the following clinical criteria:
Key exclusion criteria (4 listed)
- Known ongoing pneumonia
- Patient younger than 18 years old
- Mechanical ventilation <48 hours
- Contraindication to bronchoscopy
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 |
|---|---|---|
| Lung ultrasound examinationLung ultrasound (LUS) is increasingly being used at the bedside for assessing alveolar-interstitial syndrome, lung consolidation, pneumonia, pneumothorax, and pleural effusion. It could be an easily repeatable noninvasive tool for diagnosis of ventilator associated pneumonia | Other | Patients with suspected VAP |
Primary outcome
ventilator-associated pneumonia.
Time frame: up to 30days
Ventilator associated pneumonia is diagnosed when patient has a positive broncho alveolar lavage (positive cultiure >10*3 CFU/ml) and clinical criteria (◦Body temperature ≥ 38.5° C (101° F) or < 36° C (97° F) * White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells * Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300 * Purulent respiratory secretion)
5 secondary outcomes
Duration of stay in ICU
Time frame: up to 60 days
Duration of hospital say
Time frame: up to 60 days
Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose ventilator-associated pneumonia
Time frame: up to 30 days
sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with the CPIS to diagnose ventilator-associated pneumonia
Time frame: up to 30 days
sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with unprotected tracheal aspirate to diagnose ventilator-associated pneumonia
Time frame: up to 30 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 7 Sep 2017.
- Background: PubMed 19633538Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
- Background: PubMed 20851923Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
- Derived from this study: PubMed 27784331Wang G, Ji X, Xu Y, Xiang X. Lung ultrasound: a promising tool to monitor ventilator-associated pneumonia in critically ill patients. Crit Care. 2016 Oct 27;20(1):320. doi: 10.1186/s13054-016-1487-y.
- Derived from this study: PubMed 26836896Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: 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 Fondation Hôpital Saint-Joseph at 2 sites in 2 countries.
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 7 inclusion and 4 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, 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?
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?
ventilator-associated pneumonia. (time frame: up to 30days). 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 NCT02244723, which also lists 4 linked publications.
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 Sep 2017.