VAP - Ventilator Associated PneumoniaNCT07138651
Effect of the Aspiration Care Bundle on Preventing VAP
A study testing Aspiration care bundle in people with VAP - Ventilator Associated Pneumonia and Care, run by Akdeniz University.
Trial summary
Many pharmacological and non-pharmacological interventions are used to prevent ventilator-associated pneumonia (VAP). Nurses are directly responsible for implementing non-pharmacological interventions and therefore have an important role in preventing VAP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia, Care, Bundle Care
- What is being tested?
- Aspiration care bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted to the pulmonary intensive care unit
- Aged 18 years or older
- Connected to mechanical ventilation via ETT/TT
- Glasgow Coma Scale score: 8 or higher
- Remaining in the intensive care unit for at least 24 hours
- Patients who have not previously been diagnosed with ventilator-associated pneumonia will be included in the study.
Who cannot join
- Transferred from the pulmonary intensive care unit to another clinic
- Diagnosed with ventilator-associated pneumonia within the first 24 hours
- Glasgow Coma Scale score fell below 8 during the study
- Deceased at the time of data collection
- Patients who developed any complications related to aspiration (atelectasis, hypoxemia, bradypnea, etc.) prior to the study will be excluded from the study.
About this study
Official title: Yoğun Bakım Hastalarına Uygulanan Aspirasyon Bakım Paketinin Ventilatör İlişkili Pnömoni Gelişimini Önlemeye Etkisi: Yarı Deneysel Çalışma
Many pharmacological and non-pharmacological interventions are used to prevent ventilator-associated pneumonia (VAP). Nurses are directly responsible for implementing non-pharmacological interventions and therefore have an important role in preventing VAP. The most important non-pharmacological nursing interventions to prevent VAP are hand hygiene and oral care. In addition, the head of the bed should be elevated to 30°-45°, head pressure should be monitored, and subglottic aspiration should be performed. Various care packages have been developed to prevent VAP. It has been determined that these care packages reduce the incidence of VAP. The aim of this study was to investigate the effect of the aspiration care package applied in the intensive care unit on preventing the development of ventilator-associated pneumonia, and it was planned as a quasi-experimental study.
Read the detailed description
Ventilator-associated pneumonia (VAP) is defined as pneumonia that develops 48 hours after intubation in patients who did not have pneumonia at the time of intubation and who were placed on mechanical ventilation. VAP is known to be one of the most common healthcare-associated infections in patients admitted to intensive care units. VAP is a common nosocomial infection in intensive care units, and its consequences include high mortality, prolonged intensive care unit stay, and increased healthcare costs. There are two types of VAP: "early-onset" and "late-onset." Early-onset VAP develops 48-96 hours after intubation and is caused by microorganisms that are sensitive to antibiotic treatment. The microorganisms responsible for early-onset VAP include Methicillin-Sensitive Staphylococcus Aureus (MSSA), Streptococcus Pneumoniae, Haemophilus Influenzae, and Moraxella Catarrhalis. Late-onset VAP develops 96 hours after intubation and is caused by multidrug-resistant microorganisms. Microorganisms seen in late-onset VAP include Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus (MRSA), Klebsiella species, and Acinetobacter baumannii. Clinical findings observed in patients with VAP include fever (body temperature above 38 degrees Celsius), leukocytosis (white blood cell count above 10,000 mm3), purulent secretion or increased secretion, and new or progressive infiltration on chest X-ray. Many pharmacological and non-pharmacological interventions are used to prevent VAP. Nurses are directly responsible for implementing non-pharmacological interventions and therefore have an important role in preventing VAP. The most important non-pharmacological nursing interventions to prevent VAP are hand hygiene and oral care. In addition, the head of the bed should be elevated to 30°-45°, head pressure should be monitored, and subglottic aspiration should be performed. Various care packages have been developed to prevent VAP. It has been determined that these care packages reduce the incidence of VAP. The aim of this study was to investigate the effect of the aspiration care package applied in the intensive care unit on preventing the development of ventilator-associated pneumonia, and it was planned as a quasi-experimental study.
- Being tested
- Aspiration care bundle
- 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.
Aspiration care bundleOther
Evidence-based aspiration care protocol
| Study group | Role | What they receive |
|---|---|---|
| Conrol group | Other | Rutin aspiration application Receives: Other: Aspiration care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pulmonary Infection Score
Clinical Pulmonary Infection Score (CPIS):
The CPIS is a clinical scoring system developed to facilitate the diagnosis of ventilator-associated pneumonia (VAP). It combines clinical, radiological, physiological, and microbiological parameters to provide a structured assessment of pulmonary infection in critically ill patients.
Parameters evaluated in CPIS:
- Temperature (fever or hypothermia)
- Leukocyte count (leukocytosis, leukopenia, or normal range)
- Tracheal secretions (absence, non-purulent, or purulent)
- Arterial oxygenation (PaO₂/FiO₂ ratio)
- Chest radiograph findings (infiltrates: absent, diffuse, or localized)
- Culture of tracheal aspirate (no growth, light, or heavy growth of pathogenic bacteria) A total score >6 is commonly considered suggestive of pneumonia.
Measured: Through study completion, an average of 35 days
VAP rate monitoring form
Measured: Through study completion, an average of 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Terzi, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138651
- Sponsor's protocol ID
- 2025/415
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoğun Bakım Hastalarına Uygulanan Aspirasyon Bakım Paketinin Ventilatör İlişkili Pnömoni Gelişimini Önlemeye Etkisi: Yarı Deneysel Çalışma
- ClinicalTrials.gov ID
- NCT07138651
- Acronym / sponsor ID
- 2025/415
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 24 Aug 2025 (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.
Many pharmacological and non-pharmacological interventions are used to prevent ventilator-associated pneumonia (VAP). Nurses are directly responsible for implementing non-pharmacological interventions and therefore have an important role in preventing VAP. The most important non-pharmacological nursing interventions to prevent VAP are hand hygiene and oral care. In addition, the head of the bed should be elevated to 30°-45°, head pressure should be monitored, and subglottic aspiration should be performed. Various care packages have been developed to prevent VAP. It has been determined that these care packages reduce the incidence of VAP. The aim of this study was to investigate the effect of the aspiration care package applied in the intensive care unit on preventing the development of ventilator-associated pneumonia, and it was planned as a quasi-experimental study.
Detailed description
Ventilator-associated pneumonia (VAP) is defined as pneumonia that develops 48 hours after intubation in patients who did not have pneumonia at the time of intubation and who were placed on mechanical ventilation. VAP is known to be one of the most common healthcare-associated infections in patients admitted to intensive care units. VAP is a common nosocomial infection in intensive care units, and its consequences include high mortality, prolonged intensive care unit stay, and increased healthcare costs. There are two types of VAP: "early-onset" and "late-onset." Early-onset VAP develops 48-96 hours after intubation and is caused by microorganisms that are sensitive to antibiotic treatment. The microorganisms responsible for early-onset VAP include Methicillin-Sensitive Staphylococcus Aureus (MSSA), Streptococcus Pneumoniae, Haemophilus Influenzae, and Moraxella Catarrhalis. Late-onset VAP develops 96 hours after intubation and is caused by multidrug-resistant microorganisms. Microorganisms seen in late-onset VAP include Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus (MRSA), Klebsiella species, and Acinetobacter baumannii. Clinical findings observed in patients with VAP include fever (body temperature above 38 degrees Celsius), leukocytosis (white blood cell count above 10,000 mm3), purulent secretion or increased secretion, and new or progressive infiltration on chest X-ray. Many pharmacological and non-pharmacological interventions are used to prevent VAP. Nurses are directly responsible for implementing non-pharmacological interventions and therefore have an important role in preventing VAP. The most important non-pharmacological nursing interventions to prevent VAP are hand hygiene and oral care. In addition, the head of the bed should be elevated to 30°-45°, head pressure should be monitored, and subglottic aspiration should be performed. Various care packages have been developed to prevent VAP. It has been determined that these care packages reduce the incidence of VAP. The aim of this study was to investigate the effect of the aspiration care package applied in the intensive care unit on preventing the development of ventilator-associated pneumonia, and it was planned as a quasi-experimental study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Conrol group | Other | Other: Aspiration care bundleRutin aspiration application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients admitted to the pulmonary intensive care unit
- Aged 18 years or older
- Connected to mechanical ventilation via ETT/TT
- Glasgow Coma Scale score: 8 or higher
- Remaining in the intensive care unit for at least 24 hours
Key exclusion criteria (5 listed)
- Transferred from the pulmonary intensive care unit to another clinic
- Diagnosed with ventilator-associated pneumonia within the first 24 hours
- Glasgow Coma Scale score fell below 8 during the study
- Deceased at the time of data collection
- Patients who developed any complications related to aspiration (atelectasis, hypoxemia, bradypnea, etc.) prior to the study will be excluded from the study.
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 |
|---|---|---|
| Aspiration care bundleEvidence-based aspiration care protocol | Other | Conrol group |
Primary outcome
Clinical Pulmonary Infection Score
Time frame: Through study completion, an average of 35 days
Clinical Pulmonary Infection Score (CPIS): The CPIS is a clinical scoring system developed to facilitate the diagnosis of ventilator-associated pneumonia (VAP). It combines clinical, radiological, physiological, and microbiological parameters to provide a structured assessment of pulmonary infection in critically ill patients. Parameters evaluated in CPIS: * Temperature (fever or hypothermia) * Leukocyte count (leukocytosis, leukopenia, or normal range) * Tracheal secretions (absence, non-purulent, or purulent) * Arterial oxygenation (PaO₂/FiO₂ ratio) * Chest radiograph findings (infiltrates: absent, diffuse, or localized) * Culture of tracheal aspirate (no growth, light, or heavy growth of pathogenic bacteria) A total score >6 is commonly considered suggestive of pneumonia.
VAP rate monitoring form
Time frame: Through study completion, an average of 35 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 Aspiration care bundle in people with VAP - Ventilator Associated Pneumonia and Care, run by Akdeniz 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Pulmonary Infection Score (time frame: Through study completion, an average of 35 days). The study lists 2 primary outcomes in all. 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 29 Aug 2025.