Ventilator Associated PneumoniaNCT04911244
Diagnostic Modalities for VAP Detection
A study testing bronchoalveolar lavage in people with Ventilator Associated Pneumonia, run by Assiut University.
Trial summary
asses diagnostic performance of different methods for detection of ventilator associated pneumonia. 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?
- bronchoalveolar lavage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Feb 2020
- 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 adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.
- who had:
- Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6.
- Or 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).
- Purulent tracheal secretions.
- Hypoxemia with PaO2 <60 mmHg or a PaO2 / FiO2 <300.
Who cannot join
- Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation.
- Patients who are contraindicated for bronchoscopy
About this study
Official title: Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia
asses diagnostic performance of different methods for detection of ventilator associated pneumonia.
Read the detailed description
Ventilator associated pneumonia (VAP) is a common cause of nosocomial infection, that can complicate mechanical ventilation and is related to significant utilization of health-care resources.
The diagnosis of VAP is subjected to considerable interobserver variability. The Centers for Disease Control and Prevention (CDC) definition of VAP uses a combination of clinical, radiographic, and micro-biological criteria for diagnosis, but in the absence of a definite diagnostic test, the accurate diagnosis and treatment of VAP is limited.
The clinical pulmonary infection score (CPIS) was developed to objectively diagnose VAP and assign points on the basis of clinical and radiographic data, but its role in diagnosing pneumonia remains controversial .
Lung ultrasound (LUS) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. It has been successfully applied for monitoring aeration and monitoring antibiotic efficacy in ventilator-associated pneumonia (VAP). However, no scientific evidence is yet available on whether LUS reliably improves the diagnosis of VAP.
Quantitative bacterial cultures of the specimen obtained from the lower airways using bronchoscope were proposed for VAP diagnosis with a cut off value of 104 colony-forming unit/ml. However, microbiological cultures cannot guide the early clinical management of patients with a suspected VAP, as they need at least 24 hours for preliminary results. So, starting antibiotics remains a challenge. Moreover, bronchoscopy is not always easy to perform in hypoxemic patients and not promptly available in all ICUs. Therefore, it can be replaced by tracheal aspirate microbiological samples.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- bronchoalveolar lavage
- 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.
bronchoalveolar lavageDiagnostic test
Also called protected endotracheal aspirate
endobronchial sampling through bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| VAP group | Experimental | patients confirmed diagnosis of VAP with bronchoalveolar lavage Receives: Diagnostic Test: bronchoalveolar lavage |
| Non VAP group | Experimental | patients confirmed not VAP with bronchoalveolar lavage Receives: Diagnostic Test: bronchoalveolar lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detected diagnostic accuracy of chest ultrasound in VAP.
To identify sensitivity and specificity of chest ultrasound in VAP diagnosis
Measured: 3 years
To detected diagnostic accuracy of protected endotracheal aspirate in VAP.
To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis
Measured: 3 years
To detected diagnostic accuracy of usual endotracheal aspirate in VAP.
To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis
Measured: 3 years
To detected diagnostic accuracy of chest X-ray in VAP.
To identify sensitivity and specificity of chest X-ray in VAP diagnosis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study startAug 2016
- Primary completionOct 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Refaat Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911244
- Sponsor's protocol ID
- VAP diagnosis
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nair GB, Niederman MS. Ventilator-associated pneumonia: present understanding and ongoing debates. Intensive Care Med. 2015 Jan;41(1):34-48. doi: 10.1007/s00134-014-3564-5. Epub 2014 Nov 27.
PubMed 25427866Bouhemad 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 19633538Mongodi 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT04911244
- Acronym / sponsor ID
- VAP diagnosis
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 2 Jun 2021 (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.
asses diagnostic performance of different methods for detection of ventilator associated pneumonia.
Detailed description
Ventilator associated pneumonia (VAP) is a common cause of nosocomial infection, that can complicate mechanical ventilation and is related to significant utilization of health-care resources.
The diagnosis of VAP is subjected to considerable interobserver variability. The Centers for Disease Control and Prevention (CDC) definition of VAP uses a combination of clinical, radiographic, and micro-biological criteria for diagnosis, but in the absence of a definite diagnostic test, the accurate diagnosis and treatment of VAP is limited.
The clinical pulmonary infection score (CPIS) was developed to objectively diagnose VAP and assign points on the basis of clinical and radiographic data, but its role in diagnosing pneumonia remains controversial .
Lung ultrasound (LUS) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. It has been successfully applied for monitoring aeration and monitoring antibiotic efficacy in ventilator-associated pneumonia (VAP). However, no scientific evidence is yet available on whether LUS reliably improves the diagnosis of VAP.
Quantitative bacterial cultures of the specimen obtained from the lower airways using bronchoscope were proposed for VAP diagnosis with a cut off value of 104 colony-forming unit/ml. However, microbiological cultures cannot guide the early clinical management of patients with a suspected VAP, as they need at least 24 hours for preliminary results. So, starting antibiotics remains a challenge. Moreover, bronchoscopy is not always easy to perform in hypoxemic patients and not promptly available in all ICUs. Therefore, it can be replaced by tracheal aspirate microbiological samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAP group | Experimental | Diagnostic Test: bronchoalveolar lavagepatients confirmed diagnosis of VAP with bronchoalveolar lavage |
| Non VAP group | Experimental | Diagnostic Test: bronchoalveolar lavagepatients confirmed not VAP with bronchoalveolar lavage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.
- Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6.
- Or new or extension of a radiological image with at least two of the following clinical criteria:
Key exclusion criteria (2 listed)
- Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation.
- Patients who are contraindicated for 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 |
|---|---|---|
| bronchoalveolar lavageAlso: protected endotracheal aspirateendobronchial sampling through bronchoscopy | Diagnostic test | Non VAP group, VAP group |
Primary outcome
To detected diagnostic accuracy of chest ultrasound in VAP.
Time frame: 3 years
To identify sensitivity and specificity of chest ultrasound in VAP diagnosis
To detected diagnostic accuracy of protected endotracheal aspirate in VAP.
Time frame: 3 years
To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis
To detected diagnostic accuracy of usual endotracheal aspirate in VAP.
Time frame: 3 years
To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis
To detected diagnostic accuracy of chest X-ray in VAP.
Time frame: 3 years
To identify sensitivity and specificity of chest X-ray in VAP diagnosis
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 2 Jun 2021.
- Background: PubMed 25427866Nair GB, Niederman MS. Ventilator-associated pneumonia: present understanding and ongoing debates. Intensive Care Med. 2015 Jan;41(1):34-48. doi: 10.1007/s00134-014-3564-5. Epub 2014 Nov 27.
- 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 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoalveolar lavage in people with Ventilator Associated Pneumonia, run by Assiut University.
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 8 inclusion and 2 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 2 Jun 2021. 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?
To detected diagnostic accuracy of chest ultrasound in VAP. (time frame: 3 years). The study lists 4 primary outcomes in all. 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 NCT04911244, which also lists 3 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 2 Jun 2021.