NCT07138651

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

August 8, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

August 8, 2025

Last Update Submit

August 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Through study completion, an average of 35 days

  • VAP rate monitoring form

    Through study completion, an average of 35 days

Study Arms (1)

Conrol group

OTHER

Rutin aspiration application

Other: Aspiration care bundle

Interventions

Evidence-based aspiration care protocol

Conrol group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Banu Terzi

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 24, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share