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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04107363
Other study ID # EGE.0.20.05.00/EY/739/924
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2015
Est. completion date June 30, 2019

Study information

Verified date September 2019
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Oropharyngeal aspiration before changing the position of the patient
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.
Other:
Control 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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ayse AKBIYIK

Outcome

Type Measure Description Time frame Safety issue
Primary 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]
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