Ventilator-associated PneumoniaPAVMNCT02536547
Diagnostic Value of Pulmonary Ultrasound in the Diagnosis of Ventilator-associated Pneumoniae
An observational study of Ventilator-associated Pneumonia and Sepsis, run by Fondation Hôpital Saint-Joseph.
Trial summary
This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia, Sepsis
- What is being tested?
- VAP
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2014
- 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: All patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following criteria : fever ≥38.5 ° C or <36, 5 ° C, leukocytosis> 10 * 103 / ml or leukopenia <4 * 103 / ml; secretions purulent tracheal; reduction in PaO2 / (FiO2) <300 or PaO2 <60 mmHg)
Who may be able to join
- Patients in mechanical ventilation for at least 48 hours
- and new or extension of a radiological image
- with at least two of the following clinical criteria:
- Body temperature ≥ 38.5 ° C or <36 ° C
- Leukocytes> 10 * 103 / ml or <4 * 103 / ml or> 10% immature cells (in the absence of other known causes).
- hypoxemia with PaO 2 <60 mmHg or a P / F <300
- secretions purulent tracheal
Who cannot join
- Patient with known pneumonia
- Patient under 18 years
- Mechanical ventilation <48h
- contraindication of pulmonary endoscopy
About this study
This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP).
Read the detailed description
Diagnosis and monitoring iconographic lung infection is essentially limited to chest radiography. But this one to bed is a source of information generally unreliable routine.
Lung ultrasound is now an additional technique for confirmation of diagnosis and followed by community acquired pneumonia and monitoring of ventilator-associated pneumonia. The specific pathophysiology of VAP makes particularly efficient lung ultrasound in the diagnosis and monitoring of these attacks. The patient mechanically ventilated, the colonization of the airways is responsible for a continuous seeding of the tracheobronchial tree. As the lesions are scattered throughout the lung parenchyma and are centered on a bronchiole; although there is a predominance of households in the areas most dependent lung. VAP is therefore characterized by inflammatory tissue expansion to the periphery, predominant at the lower lobes and partnering with a ventilation loss varies with the severity of the pneumonia.
Thus, it can be found at an early stage some cells infected around a bronchiole in contact with infected acini normally ventilated. At an advanced stage, this extension to the whole parenchyma results in the widespread presence of small outbreaks in pleural. They are easily and specifically detected by ultrasound in the form of vertical artifacts irregular spacing (irregular Lines B) or small pictures (<0.5 cm) rounded HYPOECHOIC (jucta pleural consolidation) for reliable diagnosis of VAP. The success of an antibiotic is detected by the disappearance of B lines and pleural jucta consolidations. The failure of antibiotic therapy by the appearance of new jucta pleural consolidations which may merge giving lobar consolidation. Community-acquired pneumonia is characterized by the spread of infection in a home adjacent pulmonary segments by providing a systematized typical lobar reached. The diagnosis and monitoring of community-acquired pneumonia is mainly based on monitoring the number and size of household lobar consolidation which is not sufficient for pneumonia Ventilator. This latest study shows that the intensity ultrasound signs is proportional to the extension of outbreaks (lobar consolidations homes and mini homes jucta pleural consolidation). Moreover unlike biological biomarkers such as procalcitonin, it does not reflect the intensity of inflammation.
- Conditions
- Ventilator-associated Pneumonia, Sepsis
- Being tested
- VAP
- Keywords
- Clinical pulmonary infection score, sepsis, lung ultrasound, ventilator-associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAPDevice
all patients with suspected VAP : biochemestry microbiology lung ultrasound
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected VAP | All patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following:criteria :
fever ≥38.5 ° C or <36, 5 ° C leukocytosis> 10 * 103 / ml or leukopenia <4 * 103 / ml secretions purulent tracheal reduction in PaO2 / FiO2 <300 or PaO 2 <60 mmHg Receives: Device: VAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity and diagnostic accuracy of lung ultrasound (in pleural consolidation homes and irregular lines B, basal consolidation) only and associated with the CPIS (clinical pulmonary infection score)
Measured: 48h after mecanic ventilation
Secondary outcomes (2)
Frequency of specific sonographic signs (irregular B lines, pleural consolidation in household) during the VAP
Measured: 48h after mecanic ventilation
Diagnostic approach integrating CPIS (Clinical Pulmonary Infection Score), tracheal aspiration and lung ultrasound (LUS - Lung Ultrasound) for the early diagnosis of VAP
Measured: 48h after mecanic ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Nazionale di Ricovero e Cura per Anziani
- Responsible party
- Sponsor
- Investigators
- Bélaïd BOUHEMAD, Dr, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536547
- Sponsor's protocol ID
- 2013-A01818-37
- Acronym
- PAVM
- Status last verified
- Aug 2015
- First submitted
- 21 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Pulmonary Ultrasound in the Diagnosis of Ventilator-associated Pneumoniae
- ClinicalTrials.gov ID
- NCT02536547
- Acronym / sponsor ID
- PAVM / 2013-A01818-37
- Conditions
- Ventilator-associated Pneumonia, Sepsis
- Keywords
- Clinical pulmonary infection score, sepsis, lung ultrasound, ventilator-associated pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Istituto Nazionale di Ricovero e Cura per Anziani
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Sep 2015 (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.
This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP).
Detailed description
Diagnosis and monitoring iconographic lung infection is essentially limited to chest radiography. But this one to bed is a source of information generally unreliable routine.
Lung ultrasound is now an additional technique for confirmation of diagnosis and followed by community acquired pneumonia and monitoring of ventilator-associated pneumonia. The specific pathophysiology of VAP makes particularly efficient lung ultrasound in the diagnosis and monitoring of these attacks. The patient mechanically ventilated, the colonization of the airways is responsible for a continuous seeding of the tracheobronchial tree. As the lesions are scattered throughout the lung parenchyma and are centered on a bronchiole; although there is a predominance of households in the areas most dependent lung. VAP is therefore characterized by inflammatory tissue expansion to the periphery, predominant at the lower lobes and partnering with a ventilation loss varies with the severity of the pneumonia.
Thus, it can be found at an early stage some cells infected around a bronchiole in contact with infected acini normally ventilated. At an advanced stage, this extension to the whole parenchyma results in the widespread presence of small outbreaks in pleural. They are easily and specifically detected by ultrasound in the form of vertical artifacts irregular spacing (irregular Lines B) or small pictures (<0.5 cm) rounded HYPOECHOIC (jucta pleural consolidation) for reliable diagnosis of VAP. The success of an antibiotic is detected by the disappearance of B lines and pleural jucta consolidations. The failure of antibiotic therapy by the appearance of new jucta pleural consolidations which may merge giving lobar consolidation. Community-acquired pneumonia is characterized by the spread of infection in a home adjacent pulmonary segments by providing a systematized typical lobar reached. The diagnosis and monitoring of community-acquired pneumonia is mainly based on monitoring the number and size of household lobar consolidation which is not sufficient for pneumonia Ventilator. This latest study shows that the intensity ultrasound signs is proportional to the extension of outbreaks (lobar consolidations homes and mini homes jucta pleural consolidation). Moreover unlike biological biomarkers such as procalcitonin, it does not reflect the intensity of inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with suspected VAP | – | Device: VAPAll patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following:criteria : fever ≥38.5 ° C or <36, 5 ° C leukocytosis> 10 * 103 / ml or leukopenia <4 * 103 / ml secretions purulent tracheal reduction in PaO2 / FiO2 <300 or PaO 2 <60 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following criteria : fever ≥38.5 ° C or <36, 5 ° C, leukocytosis> 10 * 103 / ml or leukopenia <4 * 103 / ml; secretions purulent tracheal; reduction in PaO2 / (FiO2) <300 or PaO2 <60 mmHg)
Key inclusion criteria (7 listed)
- Patients in mechanical ventilation for at least 48 hours
- and new or extension of a radiological image
- Body temperature ≥ 38.5 ° C or <36 ° C
- Leukocytes> 10 * 103 / ml or <4 * 103 / ml or> 10% immature cells (in the absence of other known causes).
- hypoxemia with PaO 2 <60 mmHg or a P / F <300
Key exclusion criteria (4 listed)
- Patient with known pneumonia
- Patient under 18 years
- Mechanical ventilation <48h
- contraindication of pulmonary endoscopy
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 |
|---|---|---|
| VAPall patients with suspected VAP : biochemestry microbiology lung ultrasound | Device | patients with suspected VAP |
Primary outcome
Sensitivity, specificity and diagnostic accuracy of lung ultrasound (in pleural consolidation homes and irregular lines B, basal consolidation) only and associated with the CPIS (clinical pulmonary infection score)
Time frame: 48h after mecanic ventilation
2 secondary outcomes
Frequency of specific sonographic signs (irregular B lines, pleural consolidation in household) during the VAP
Time frame: 48h after mecanic ventilation
Diagnostic approach integrating CPIS (Clinical Pulmonary Infection Score), tracheal aspiration and lung ultrasound (LUS - Lung Ultrasound) for the early diagnosis of VAP
Time frame: 48h after mecanic ventilation
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 1 Sep 2015.
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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.
Bélaïd BOUHEMAD, Dr principal investigator
Fondation Hôpital Saint-Joseph
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-associated Pneumonia and Sepsis, run by Fondation Hôpital Saint-Joseph.
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 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity, specificity and diagnostic accuracy of lung ultrasound (in pleural consolidation homes and irregular lines B, basal consolidation) only and associated with the CPIS (clinical pulmonary infection score) (time frame: 48h after mecanic ventilation). 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 1 Sep 2015.