NCT04107363

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

September 24, 2019

Last Update Submit

September 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, about four years]

Study Arms (2)

Experimental group:

EXPERIMENTAL

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.

Procedure: Oropharyngeal aspiration before changing the position of the patient

Control group

OTHER

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).

Other: Control group:

Interventions

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.

Experimental group:

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).

Control group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details20 male and 20 female patients were included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor of Philosophy (PhD) Research Assistant

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 27, 2019

Study Start

July 1, 2015

Primary Completion

April 30, 2019

Study Completion

June 30, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share