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Oropharyngeal Aspiration to Reduce Ventilator-Related Pneumonia

Primary Purpose

Ventilator-associated Bacterial Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oropharyngeal aspiration before changing the position of the patient
Control group:
Sponsored by
Ayşe AKBIYIK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-associated Bacterial Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years of age,
  • Supported mechanical ventilation by endotracheal tube,
  • ≥ 24 hours remaining connected to mechanical ventilator,
  • Position can be changed every 2 hours during the day and 4 hours at night,
  • Patients whose relatives were approved to participate in the study.

Exclusion Criteria:

  • Pneumonia develops prior to mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
  • Positive sputum culture was taken before mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
  • Patients with diabetes mellitus,
  • Patients with contraindications for routine change of position

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental group:

    Control group

    Arm Description

    Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed.

    The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).

    Outcomes

    Primary Outcome Measures

    Incidence of Ventilator-Related Pneumonia
    Clinical Pulmonary Infection Score (CPIS) was used in the diagnosis of VAP and, VAP was diagnosed in patients whose CPIS was above 6 in the evaluation. Broncho alveolar lavage specimens were cultured for VAP agent/s. Antibiotic susceptibility of microorganisms grown in positive cultures were investigated.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    September 26, 2019
    Sponsor
    Ayşe AKBIYIK
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04107363
    Brief Title
    Oropharyngeal Aspiration to Reduce Ventilator-Related Pneumonia
    Official Title
    The Effect of Oropharyngeal Aspiration Before Position Change on Reducing the Incidence of Ventilator-Related Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    April 30, 2019 (Actual)
    Study Completion Date
    June 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ayşe AKBIYIK

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Ventilator-associated pneumonia (VAP) is one of the healthcare-related infections that is common in critically ill patients, prolongs hospital stay, significantly increases mortality and additional health care costs. Microaspiration of oropharyngeal secretions the primary pathway in the formation of VAP has led researchers to focus on the detection of applications to prevent microbial colonization. Continuous or intermittent oropharyngeal aspiration, open system aspiration versus closed system aspiration, extensive oral care, oropharyngeal aspiration prior to patient positioning are some of these applications. When the patient is turned to position, the outbreak accumulated in the oral cavity is more likely to move to the lower respiratory tract. In this study, it is assumed that aspiration of oropharyngeal secretions prior to each position change will reduce the accumulation of oral secretion in the endotracheal tube cuff and reduce aspiration of contaminated secretion and reduce the risk of developing VIP. This randomized controlled experimental study was planned to confirm the validity of this assumption. This study was a randomized controlled experimental study designed to investigate the effect of oropharyngeal aspiration on decreasing the incidence of ventilator-associated pneumonia in patients receiving mechanical ventilation. The research was conducted between July 2015 and April 2019 in anesthesiology and reanimation intensive care unit. The study was carried out with 20 patients who underwent oropharyngeal aspiration as needed and 20 patients with oropharyngeal aspiration prior to each change of position.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator-associated Bacterial Pneumonia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group:
    Arm Type
    Experimental
    Arm Description
    Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
    Intervention Type
    Procedure
    Intervention Name(s)
    Oropharyngeal aspiration before changing the position of the patient
    Intervention Description
    Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed.
    Intervention Type
    Other
    Intervention Name(s)
    Control group:
    Intervention Description
    The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
    Primary Outcome Measure Information:
    Title
    Incidence of Ventilator-Related Pneumonia
    Description
    Clinical Pulmonary Infection Score (CPIS) was used in the diagnosis of VAP and, VAP was diagnosed in patients whose CPIS was above 6 in the evaluation. Broncho alveolar lavage specimens were cultured for VAP agent/s. Antibiotic susceptibility of microorganisms grown in positive cultures were investigated.
    Time Frame
    Through study completion, about four years]

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    20 male and 20 female patients were included in the study.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Over 18 years of age, Supported mechanical ventilation by endotracheal tube, ≥ 24 hours remaining connected to mechanical ventilator, Position can be changed every 2 hours during the day and 4 hours at night, Patients whose relatives were approved to participate in the study. Exclusion Criteria: Pneumonia develops prior to mechanical ventilation support or within the first 48 hours following mechanical ventilation support, Positive sputum culture was taken before mechanical ventilation support or within the first 48 hours following mechanical ventilation support, Patients with diabetes mellitus, Patients with contraindications for routine change of position

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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