Ventilator Associated PneumoniaNCT03266380
Risk Factors and Common Preventive Measures for Ventilator Associated Pneumonia in Patients With Severe Traumatic Brain Injury
An observational study of Ventilator Associated Pneumonia, run by Assiut University.
Trial summary
The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- observational
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 30 Dec 2019
- 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 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patients are divided into three groups, as follows: patients who donot develop VAP, those who develop early onset VAP, and those who develop late-onset VAP with no age or sex predliction
Who may be able to join
- - All patients with TBI who are on MV for >48 h after the initial evaluation.
- Patients are transferred either from the emergency room directly to the ICU, or they are transferred to the operating room first and are then admitted to the ICU after surgery.
- Patients intubated outside the hospital and who had no side effects are also included.
Who cannot join
- - Patients with documented gastric aspiration, recent antibiotic therapy, 2 days of hospitalization in the preceding 30 days, residence in a nursing home or extended care facility, home therapy, or an underlying malignancy are excluded.
- Patients who are transferred within the hospital if there was an accident or change in the ventilator system, or who have other known risk factors for developing pneumonia, are also excluded.
About this study
The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP
Read the detailed description
Ventilator-associated pneumonia (VAP) is a type of nosocomial pneumonia that occurs in patients who receive >48 h of mechanical ventilation (MV). Early onset VAP occurs during the first 4 days of MV and is usually caused by antibiotic-sensitive bacteria. The increased systemic inflammatory response in patients with a head trauma may predispose them to develop early-onset VAP1,2. Late-onset VAP develops 5 days after initiating MV and is caused by multidrug resistant (MDR) pathogens3,4.
Patients with traumatic brain injury (TBI) are at high risk of infection, particularly nosocomial infections, during treatment in the intensive care unit (ICU) 5-7, where the incidence of VAP can be as high as 50%. The duration of MV usually influences the type of organism that causes VAP8. Early-onset VAP is caused by antibiotic-sensitive pathogens, whereas late-onset VAP is caused by MDR bacteria, which are more difficult to treat. The microbiological environment can have a marked influence on VAP isolates, particularly during late-onset VAP, but it also influences early-onset VAP9. Patients who acquire VAP have longer ICU stays, higher morbidity and mortality, and a greater number of infectious agents10,11. The risk factors for developing VAP are diverse, and the pathogenesis of intra-hospital infections is complex. Common VAP preventive measures such as early mobility, the daily interruption of sedation, and a readiness-to-extubate assessment may not be applicable because of associated injuries such as severe chest trauma, intra-abdominal bleeding, and other organ damage. Hence, VAP diagnosis can be difficult in a setting of multiple trauma, and significant variations in the diagnosis and management of VAP remain8.
The upper respiratory tract of the majority of mechanically-ventilated patient is colonized with potentially pathogenic microorganisms. This was first established in a study in 1969 that reported the presence of enteric gram-negative bacteria in the oropharynx of 75 percent of critically ill patients8. A proposed explanation is bacterial overgrowth of the upper gastrointestinal tract and retrograde movement. Aspiration of secretions containing these pathogens provides a means for infection of the sterile bronchial tree. Another study published in 2007 confirmed the presence of similar pathogenic microorganisms in the lower respiratory tract of intubated patients by comparing DNA samples from bacteria on the tongue and obtained from bronchoalveolar lavage (BAL)12.
Prevention of VAP:
The use of Non-invasive positive pressure ventilation NPPV has been shown to significantly lower the risk of VAP and has also demonstrated a mortality benefit in randomized studies conducted using patients with a variety of illnesses10, daily weaning trials and sedation holidays have been repeatedly described and validated as strategies that limit the time of mechanical ventilation13,14.
re-intubation is associated with a higher risk of VAP due to higher rates of aspiration15, It was previously thought that early tracheostomy might lead to better outcomes16.
Antimicrobial-coated endotracheal tubes (ETT) have been studied as a means to decrease bacterial colonization and prevent biofilm production with the ultimate hope of reducing VAP rates.
It is hypothesized that microorganisms reach the ETT either as a consequence of a contaminated oropharynx or reflux of gastric secretions29, selective digestive tract decontamination (SDD) and selective oropharyngeal decontamination (SoD) are measures in which antibiotic therapy is used to eradicate potentially pathogenic microorganisms in oral, gastric, and intestinal flora 17, 18.
Subglottic suctioning endotracheal tubes: It has been postulated that intermittently or continuously removing the secretions that pool above the ETT cuff may reduce the risk for aspiration and subsequent development of VAP. ETTs have therefore, been designed to accomplish this task through application of negative pressure to a separate port that opens above the ETT cuff19 Oral decontamination: Chlorhexidine is the oral antiseptic most rigorously studied with regards to VAP20, Iseganan and povidone iodine have also been investigated for oral decontamination. Iseganan is a topical antimicrobial with activity against grampositive and gram-negative bacteria, and yeast21 Elevation of the head of the bed is attempted to reduce aspiration of gastric content. The basis for this intervention comes from studies using radiolabelled enteral feeding solutions which have shown that aspiration of gastric contents occurs to a greater extent in supine patients than in patients in a semirecumbent position22,23 The goal of infection control is to prevent cross transmission of pathogens, which has been shown to play an important role in the development of nosocomial infections including VAP. An effective strategy should target infection control from several vantage points: education of the medical team, universal hand hygiene, use of personal protective equipment and a protocol for microbiological surveillance24
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- observational
- 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.
observationalDiagnostic test
All patients do an emergency brain computed tomography scan. Intracranial hypertension is treated with mannitol with or without a craniotomy. A third generation cephalosporin (ceftriaxone) and metronidazole are administered as antibiotic prophylaxis for accompanying wound injuries (skin and soft tissue). VAP preventive strategies that are performed in the ICU include daily interruption of sedation and a readiness to extubate assessment, early facilitation of mobility, elevating the head of the bed to 30- 45 degree, change of the ventilator circuit if visibly soiled or malfunctioning, stress ulcer prophylaxis, residual gastric volume monitoring, early parenteral nutrition, and deep venous thrombosis prophylaxis. An infusion of midazolam and propofol is to be used for sedation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury
The patients are divided into three groups, as follows: patients who donot develop VAP, those who develop early onset VAP, and those who develop late-onset VAP
- The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP.
Measured: all patients admitted to general or trauma ICU in assiut university hospital will be recorded from january 2018 to december 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion30 Dec 2019 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed mahmoud abdelaziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266380
- Sponsor's protocol ID
- VAP
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Common Preventive Measures for Ventilator Associated Pneumonia in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03266380
- Acronym / sponsor ID
- VAP
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 30 Aug 2017 (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.
The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP
Detailed description
Ventilator-associated pneumonia (VAP) is a type of nosocomial pneumonia that occurs in patients who receive >48 h of mechanical ventilation (MV). Early onset VAP occurs during the first 4 days of MV and is usually caused by antibiotic-sensitive bacteria. The increased systemic inflammatory response in patients with a head trauma may predispose them to develop early-onset VAP1,2. Late-onset VAP develops 5 days after initiating MV and is caused by multidrug resistant (MDR) pathogens3,4.
Patients with traumatic brain injury (TBI) are at high risk of infection, particularly nosocomial infections, during treatment in the intensive care unit (ICU) 5-7, where the incidence of VAP can be as high as 50%. The duration of MV usually influences the type of organism that causes VAP8. Early-onset VAP is caused by antibiotic-sensitive pathogens, whereas late-onset VAP is caused by MDR bacteria, which are more difficult to treat. The microbiological environment can have a marked influence on VAP isolates, particularly during late-onset VAP, but it also influences early-onset VAP9. Patients who acquire VAP have longer ICU stays, higher morbidity and mortality, and a greater number of infectious agents10,11. The risk factors for developing VAP are diverse, and the pathogenesis of intra-hospital infections is complex. Common VAP preventive measures such as early mobility, the daily interruption of sedation, and a readiness-to-extubate assessment may not be applicable because of associated injuries such as severe chest trauma, intra-abdominal bleeding, and other organ damage. Hence, VAP diagnosis can be difficult in a setting of multiple trauma, and significant variations in the diagnosis and management of VAP remain8.
The upper respiratory tract of the majority of mechanically-ventilated patient is colonized with potentially pathogenic microorganisms. This was first established in a study in 1969 that reported the presence of enteric gram-negative bacteria in the oropharynx of 75 percent of critically ill patients8. A proposed explanation is bacterial overgrowth of the upper gastrointestinal tract and retrograde movement. Aspiration of secretions containing these pathogens provides a means for infection of the sterile bronchial tree. Another study published in 2007 confirmed the presence of similar pathogenic microorganisms in the lower respiratory tract of intubated patients by comparing DNA samples from bacteria on the tongue and obtained from bronchoalveolar lavage (BAL)12.
Prevention of VAP:
The use of Non-invasive positive pressure ventilation NPPV has been shown to significantly lower the risk of VAP and has also demonstrated a mortality benefit in randomized studies conducted using patients with a variety of illnesses10, daily weaning trials and sedation holidays have been repeatedly described and validated as strategies that limit the time of mechanical ventilation13,14.
re-intubation is associated with a higher risk of VAP due to higher rates of aspiration15, It was previously thought that early tracheostomy might lead to better outcomes16.
Antimicrobial-coated endotracheal tubes (ETT) have been studied as a means to decrease bacterial colonization and prevent biofilm production with the ultimate hope of reducing VAP rates.
It is hypothesized that microorganisms reach the ETT either as a consequence of a contaminated oropharynx or reflux of gastric secretions29, selective digestive tract decontamination (SDD) and selective oropharyngeal decontamination (SoD) are measures in which antibiotic therapy is used to eradicate potentially pathogenic microorganisms in oral, gastric, and intestinal flora 17, 18.
Subglottic suctioning endotracheal tubes: It has been postulated that intermittently or continuously removing the secretions that pool above the ETT cuff may reduce the risk for aspiration and subsequent development of VAP. ETTs have therefore, been designed to accomplish this task through application of negative pressure to a separate port that opens above the ETT cuff19 Oral decontamination: Chlorhexidine is the oral antiseptic most rigorously studied with regards to VAP20, Iseganan and povidone iodine have also been investigated for oral decontamination. Iseganan is a topical antimicrobial with activity against grampositive and gram-negative bacteria, and yeast21 Elevation of the head of the bed is attempted to reduce aspiration of gastric content. The basis for this intervention comes from studies using radiolabelled enteral feeding solutions which have shown that aspiration of gastric contents occurs to a greater extent in supine patients than in patients in a semirecumbent position22,23 The goal of infection control is to prevent cross transmission of pathogens, which has been shown to play an important role in the development of nosocomial infections including VAP. An effective strategy should target infection control from several vantage points: education of the medical team, universal hand hygiene, use of personal protective equipment and a protocol for microbiological surveillance24
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients are divided into three groups, as follows: patients who donot develop VAP, those who develop early onset VAP, and those who develop late-onset VAP with no age or sex predliction
Key inclusion criteria (3 listed)
- - All patients with TBI who are on MV for >48 h after the initial evaluation.
- Patients are transferred either from the emergency room directly to the ICU, or they are transferred to the operating room first and are then admitted to the ICU after surgery.
- Patients intubated outside the hospital and who had no side effects are also included.
Key exclusion criteria (2 listed)
- - Patients with documented gastric aspiration, recent antibiotic therapy, 2 days of hospitalization in the preceding 30 days, residence in a nursing home or extended care facility, home therapy, or an underlying malignancy are excluded.
- Patients who are transferred within the hospital if there was an accident or change in the ventilator system, or who have other known risk factors for developing pneumonia, are also excluded.
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 |
|---|---|---|
| observationalAll patients do an emergency brain computed tomography scan. Intracranial hypertension is treated with mannitol with or without a craniotomy. A third generation cephalosporin (ceftriaxone) and metronidazole are administered as antibiotic prophylaxis for accompanying wound injuries (skin and soft tissue). VAP preventive strategies that are performed in the ICU include daily interruption of sedation and a readiness to extubate assessment, early facilitation of mobility, elevating the head of the bed to 30- 45 degree, change of the ventilator circuit if visibly soiled or malfunctioning, stress ulcer prophylaxis, residual gastric volume monitoring, early parenteral nutrition, and deep venous thrombosis prophylaxis. An infusion of midazolam and propofol is to be used for sedation. | Diagnostic test | – |
Primary outcome
Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury
Time frame: all patients admitted to general or trauma ICU in assiut university hospital will be recorded from january 2018 to december 2018
The patients are divided into three groups, as follows: patients who donot develop VAP, those who develop early onset VAP, and those who develop late-onset VAP • The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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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?
An observational study of 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 3 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: status not confirmed, as of the sponsor's last update on 8 Sep 2017. 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?
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?
Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury (time frame: all patients admitted to general or trauma ICU in assiut university hospital will be recorded from january 2018 to december 2018). 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 8 Sep 2017.