Ventilator Associated PneumoniaNCT02363023
Study of Different Etiologic Diagnostic Methods in Ventilator Associated Pneumonia (VAP)
An observational study of Ventilator Associated Pneumonia, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator associated pneumonia and their impact in morbimortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Collect tracheal and pulmonary secretions
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jun 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients older than 18 years admitted to the ICU of Hospital de Clínicas de Uberlândia with suspected VAP will be included in the project. from february 2015 to complete the total of 72 patients required, since provided that agree with the terms of informed consent.
Who may be able to join
- Older than 18 and clinical suspicion of VAP;
Who cannot join
- Age less than 18 years;
- Introduction or modification of antibiotic therapy due to associated diagnosis in the first 3 days of the start of the protocol;
- No agreement with informed consent or for any other reason, expose the desire to leave the protocol at any time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparative Study of Different Etiologic Diagnostic Methods in Ventilator Associated Pneumonia (VAP)
The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator associated pneumonia and their impact in morbimortality.
Read the detailed description
Ventilator associated pneumonia is defined as one that occurs 48-72h after tracheal intubation, is classified into early and late and is responsible for a mortality of 24-50% to almost 70% in some studies.
The clinical suspicion of ventilator associated pneumonia is based on the finding of new or progressive pulmonary opacity associated with two or more variables such as: fever, leukocytosis or leukopenia, and purulent pulmonary secretions.
Some studies show that the etiologic diagnosis reduces spectrum of antimicrobials and bacterial resistance, reducing hospital stay and time of mechanical ventilation, as well as treatment costs. The collection of material for quantitative culture ensures greater specificity however there is no standard method.
The investigator's hypothesis is that collection of material to confirm the etiologic diagnosis of ventilator associated pneumonia, held by bronchoscopic bronchoalveolar lavage, define the etiology in a larger number of patients when compared to the endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage.
The primary goal is evaluate and compare the sensitivity and specificity of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive (bronchoscopic bronchoalveolar lavage) regarding the collection of material for etiologic diagnosis.
The secondary objectives are determine the prevalence of ventilator associated pneumonia and antimicrobial susceptibility patterns of bacteria isolated, helping to update empirical antibiotic therapy protocols.
This is a prospective comparative observational study on etiologic methods of diagnosis. All the patients, with clinical suspicion, will be submitted to collection of tracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage. These procedures are already incorporated in the daily practice of our intensive cara unit and are routinely performed for investigation of patients with compatible framework of ventilator associated pneumonia, as availability of bronchoscopist.
Whereas an analysis of variance will be performed to compare the three interventions, with a minimum difference between the treatment means, a power of 0.95 and a significance level of 0.05, with an estimation error of 0.1, will be required a total sample of 72 patients.There will be only one group of 72 patients, in which will be held in all the three samples of the study.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Collect tracheal and pulmonary secretions
- Keywords
- Ventilator associated pneumonia, 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.
Collect tracheal and pulmonary secretionsProcedure or surgery
Collect tracheal and pulmonary secretions (endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage)
| Study group | Role | What they receive |
|---|---|---|
| VAP suspects | Collect tracheal and pulmonary secretions. All patients (n: 72) will be submitted to endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage. Receives: Procedure: Collect tracheal and pulmonary secretions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity and accuracy
Sensitivity, specificity and accuracy of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive method (bronchoscopic bronchoalveolar lavage, considered gold standard).
Sensitivity: number of true positive cultures obtained with each noninvasive method divided by the number of positive cultures obtained from bronchoscopic bronchoalveolar lavage;
Specificity: number of true negative cultures obtained with each noninvasive method divided by the number of negative cultures obtained from bronchoscopic bronchoalveolar lavage;
Accuracy: number of true positive plus true negative cultures obtained with each noninvasive method divided by the number of patients (72);
Measured: 30 days
Secondary outcomes (2)
Prevalence of ventilator associated pneumonia (cases / time period)
Number of cases of ventilator associated pneumonia divided by the number of months. We hope to reach the number of 72 patients in up to 10 months.
Measured: 10 months
Antimicrobial susceptibility patterns of bacteria isolated
All isolated bacteria will be submitted to tests for antimicrobial susceptibility and resistance pattern.
Measured: 72-96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionJun 2016
Why it stopped: Lack of resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Miquelanti Melo, Federal University of Uberlandia
- Investigators
- Rodrigo Melo, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363023
- Sponsor's protocol ID
- VAP protocol
- Status last verified
- May 2018
- First submitted
- 27 Jan 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We are still collecting data.
Publications
American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PubMed 15699079Kollef MH. What is ventilator-associated pneumonia and why is it important? Respir Care. 2005 Jun;50(6):714-21; discussion 721-4.
PubMed 15913464Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R; CDC; Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-care--associated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep. 2004 Mar 26;53(RR-3):1-36.
PubMed 15048056Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med. 1998 Sep 15;129(6):433-40. doi: 10.7326/0003-4819-129-6-199809150-00002.
PubMed 9735080Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. 2005 Oct;33(10):2184-93. doi: 10.1097/01.ccm.0000181731.53912.d9.
PubMed 16215368Rea-Neto A, Youssef NC, Tuche F, Brunkhorst F, Ranieri VM, Reinhart K, Sakr Y. Diagnosis of ventilator-associated pneumonia: a systematic review of the literature. Crit Care. 2008;12(2):R56. doi: 10.1186/cc6877. Epub 2008 Apr 21.
PubMed 18426596Bonten MJ, Bergmans DC, Stobberingh EE, van der Geest S, De Leeuw PW, van Tiel FH, Gaillard CA. Implementation of bronchoscopic techniques in the diagnosis of ventilator-associated pneumonia to reduce antibiotic use. Am J Respir Crit Care Med. 1997 Dec;156(6):1820-4. doi: 10.1164/ajrccm.156.6.9610117.
PubMed 9412561Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stephan F, Similowski T, Mercat A, Diehl JL, Sollet JP, Tenaillon A. Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial. Ann Intern Med. 2000 Apr 18;132(8):621-30. doi: 10.7326/0003-4819-132-8-200004180-00004.
PubMed 10766680Croce MA, Fabian TC, Schurr MJ, Boscarino R, Pritchard FE, Minard G, Patton JH Jr, Kudsk KA. Using bronchoalveolar lavage to distinguish nosocomial pneumonia from systemic inflammatory response syndrome: a prospective analysis. J Trauma. 1995 Dec;39(6):1134-9; discussion 1139-40. doi: 10.1097/00005373-199512000-00022.
PubMed 7500408Leo A, Galindo-Galindo J, Folch E, Guerrero A, Bosques F, Mercado R, Arroliga AC. Comparison of bronchoscopic bronchoalveolar lavage vs blind lavage with a modified nasogastric tube in the etiologic diagnosis of ventilator-associated pneumonia. Med Intensiva. 2008 Apr;32(3):115-20. doi: 10.1016/s0210-5691(08)70921-5.
PubMed 18381016Shorr AF, Sherner JH, Jackson WL, Kollef MH. Invasive approaches to the diagnosis of ventilator-associated pneumonia: a meta-analysis. Crit Care Med. 2005 Jan;33(1):46-53. doi: 10.1097/01.ccm.0000149852.32599.31.
PubMed 15644647Canadian Critical Care Trials Group. A randomized trial of diagnostic techniques for ventilator-associated pneumonia. N Engl J Med. 2006 Dec 21;355(25):2619-30. doi: 10.1056/NEJMoa052904.
PubMed 17182987Fujitani S, Yu VL. Diagnosis of ventilator-associated pneumonia: focus on nonbronchoscopic techniques (nonbronchoscopic bronchoalveolar lavage, including mini-BAL, blinded protected specimen brush, and blinded bronchial sampling) and endotracheal aspirates. J Intensive Care Med. 2006 Jan-Feb;21(1):17-21. doi: 10.1177/0885066605283094.
PubMed 16698740Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. doi: 10.1378/chest.102.5_supplement_1.557s. No abstract available.
PubMed 1424930Baselski VS, el-Torky M, Coalson JJ, Griffin JP. The standardization of criteria for processing and interpreting laboratory specimens in patients with suspected ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):571S-579S. doi: 10.1378/chest.102.5_supplement_1.571s. No abstract available.
PubMed 1424932
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Different Etiologic Diagnostic Methods in Ventilator Associated Pneumonia (VAP)
- ClinicalTrials.gov ID
- NCT02363023
- Acronym / sponsor ID
- VAP protocol
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Ventilator associated pneumonia, Bronchoalveolar lavage
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of resources.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Feb 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.
The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator associated pneumonia and their impact in morbimortality.
Detailed description
Ventilator associated pneumonia is defined as one that occurs 48-72h after tracheal intubation, is classified into early and late and is responsible for a mortality of 24-50% to almost 70% in some studies.
The clinical suspicion of ventilator associated pneumonia is based on the finding of new or progressive pulmonary opacity associated with two or more variables such as: fever, leukocytosis or leukopenia, and purulent pulmonary secretions.
Some studies show that the etiologic diagnosis reduces spectrum of antimicrobials and bacterial resistance, reducing hospital stay and time of mechanical ventilation, as well as treatment costs. The collection of material for quantitative culture ensures greater specificity however there is no standard method.
The investigator's hypothesis is that collection of material to confirm the etiologic diagnosis of ventilator associated pneumonia, held by bronchoscopic bronchoalveolar lavage, define the etiology in a larger number of patients when compared to the endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage.
The primary goal is evaluate and compare the sensitivity and specificity of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive (bronchoscopic bronchoalveolar lavage) regarding the collection of material for etiologic diagnosis.
The secondary objectives are determine the prevalence of ventilator associated pneumonia and antimicrobial susceptibility patterns of bacteria isolated, helping to update empirical antibiotic therapy protocols.
This is a prospective comparative observational study on etiologic methods of diagnosis. All the patients, with clinical suspicion, will be submitted to collection of tracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage. These procedures are already incorporated in the daily practice of our intensive cara unit and are routinely performed for investigation of patients with compatible framework of ventilator associated pneumonia, as availability of bronchoscopist.
Whereas an analysis of variance will be performed to compare the three interventions, with a minimum difference between the treatment means, a power of 0.95 and a significance level of 0.05, with an estimation error of 0.1, will be required a total sample of 72 patients.There will be only one group of 72 patients, in which will be held in all the three samples of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAP suspects | – | Procedure: Collect tracheal and pulmonary secretionsCollect tracheal and pulmonary secretions. All patients (n: 72) will be submitted to endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 18 years admitted to the ICU of Hospital de Clínicas de Uberlândia with suspected VAP will be included in the project. from february 2015 to complete the total of 72 patients required, since provided that agree with the terms of informed consent.
Key inclusion criteria (1 listed)
- Older than 18 and clinical suspicion of VAP;
Key exclusion criteria (3 listed)
- Age less than 18 years;
- Introduction or modification of antibiotic therapy due to associated diagnosis in the first 3 days of the start of the protocol;
- No agreement with informed consent or for any other reason, expose the desire to leave the protocol at any time.
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 |
|---|---|---|
| Collect tracheal and pulmonary secretionsCollect tracheal and pulmonary secretions (endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage) | Procedure or surgery | VAP suspects |
Primary outcome
Sensitivity, specificity and accuracy
Time frame: 30 days
Sensitivity, specificity and accuracy of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive method (bronchoscopic bronchoalveolar lavage, considered gold standard). Sensitivity: number of true positive cultures obtained with each noninvasive method divided by the number of positive cultures obtained from bronchoscopic bronchoalveolar lavage; Specificity: number of true negative cultures obtained with each noninvasive method divided by the number of negative cultures obtained from bronchoscopic bronchoalveolar lavage; Accuracy: number of true positive plus true negative cultures obtained with each noninvasive method divided by the number of patients (72);
2 secondary outcomes
Prevalence of ventilator associated pneumonia (cases / time period)
Time frame: 10 months
Antimicrobial susceptibility patterns of bacteria isolated
Time frame: 72-96 hours
Results and safety
The study was stopped early (reason given: Lack of resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 15699079American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
- Background: PubMed 15913464Kollef MH. What is ventilator-associated pneumonia and why is it important? Respir Care. 2005 Jun;50(6):714-21; discussion 721-4.
- Background: PubMed 15048056Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R; CDC; Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-care--associated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep. 2004 Mar 26;53(RR-3):1-36.
- Background: PubMed 9735080Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med. 1998 Sep 15;129(6):433-40. doi: 10.7326/0003-4819-129-6-199809150-00002.
- Background: PubMed 16215368Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. 2005 Oct;33(10):2184-93. doi: 10.1097/01.ccm.0000181731.53912.d9.
- Background: PubMed 18426596Rea-Neto A, Youssef NC, Tuche F, Brunkhorst F, Ranieri VM, Reinhart K, Sakr Y. Diagnosis of ventilator-associated pneumonia: a systematic review of the literature. Crit Care. 2008;12(2):R56. doi: 10.1186/cc6877. Epub 2008 Apr 21.
- Background: PubMed 9412561Bonten MJ, Bergmans DC, Stobberingh EE, van der Geest S, De Leeuw PW, van Tiel FH, Gaillard CA. Implementation of bronchoscopic techniques in the diagnosis of ventilator-associated pneumonia to reduce antibiotic use. Am J Respir Crit Care Med. 1997 Dec;156(6):1820-4. doi: 10.1164/ajrccm.156.6.9610117.
- Background: PubMed 10766680Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stephan F, Similowski T, Mercat A, Diehl JL, Sollet JP, Tenaillon A. Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial. Ann Intern Med. 2000 Apr 18;132(8):621-30. doi: 10.7326/0003-4819-132-8-200004180-00004.
- Background: PubMed 7500408Croce MA, Fabian TC, Schurr MJ, Boscarino R, Pritchard FE, Minard G, Patton JH Jr, Kudsk KA. Using bronchoalveolar lavage to distinguish nosocomial pneumonia from systemic inflammatory response syndrome: a prospective analysis. J Trauma. 1995 Dec;39(6):1134-9; discussion 1139-40. doi: 10.1097/00005373-199512000-00022.
- Background: PubMed 18381016Leo A, Galindo-Galindo J, Folch E, Guerrero A, Bosques F, Mercado R, Arroliga AC. Comparison of bronchoscopic bronchoalveolar lavage vs blind lavage with a modified nasogastric tube in the etiologic diagnosis of ventilator-associated pneumonia. Med Intensiva. 2008 Apr;32(3):115-20. doi: 10.1016/s0210-5691(08)70921-5.
- Background: PubMed 15644647Shorr AF, Sherner JH, Jackson WL, Kollef MH. Invasive approaches to the diagnosis of ventilator-associated pneumonia: a meta-analysis. Crit Care Med. 2005 Jan;33(1):46-53. doi: 10.1097/01.ccm.0000149852.32599.31.
- Background: PubMed 17182987Canadian Critical Care Trials Group. A randomized trial of diagnostic techniques for ventilator-associated pneumonia. N Engl J Med. 2006 Dec 21;355(25):2619-30. doi: 10.1056/NEJMoa052904.
- Individual participant dataSharing planned: Undecided. We are still collecting data.
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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.
Rodrigo Melo principal investigator
Federal University of Uberlandia
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 Federal University of Uberlandia at 1 site in Brazil.
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 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: stopped early, as of the sponsor's last update on 3 May 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 Brazil. 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 was stopped early (reason given: Lack of resources.). Results are not available in the source record.
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 accuracy (time frame: 30 days). 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 NCT02363023, which also lists 17 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 3 May 2018.