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Not yet recruitingNCT07138651Updated Aug 29, 2025

Effect of the Aspiration Care Bundle on Preventing VAP

An interventional study of Aspiration care bundle in VAP - Ventilator Associated Pneumonia, Care and Bundle Care, sponsored by Akdeniz University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Akdeniz University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • VAP - Ventilator Associated Pneumonia
  • Care
  • Bundle Care
  • Aspiration
  • Nursing Care
03

In context

Pneumonia, Ventilator-Associated

392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.

This study's planned enrollment of 60 is below the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Conrol group

    Rutin aspiration application

    Other: Aspiration care bundle

Interventions

  • OtherAspiration care bundle

    Evidence-based aspiration care protocol

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 35 days

  2. VAP rate monitoring form

    Time frame: Through study completion, an average of 35 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07138651
Lead sponsor
Akdeniz University
Responsible party
Banu Terzi (Assoc. Prof. Banu Terzi, Akdeniz University) — Principal investigator
First posted
Aug 24, 2025
Start date
Sep 15, 2025 (estimated)
Primary completion
Jun 15, 2026 (estimated)
Completion
Sep 15, 2026 (estimated)
Last update
Aug 29, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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