Oral Care to Prevent Ventilator-associated Pneumonia

Investigation of the Effect of Oral Care Given by Two Different Methods in Patients Connected to Mechanical Ventilators on the Development of Ventilator-AssociatedPneumonia

This study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

Study Overview

• Status: Completed
• Conditions: Ventilators, Mechanical; Oral Hygiene, Oral Health
• Intervention / Treatment: Combination product: One group received standard oral care.; Combination product: It was applied to the other group by aspiration.

Detailed Description

The universe of this research, which was designed as a semi-experimental study, is composed of patients connected to the mechanical ventilator lying in Atatürk University Training and Research Hospital Anesthesia and Reanimation Intensive Care Unit between September 2019 and February 2020. A total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion criteria of the study. In the data collection phase, 'Patient Identifier Information Form', 'Patient Monitoring Form', 'Oral Assessment Scale' and 'Tracheal Aspirate Culture Result Form' were used. In the evaluation of the data, number and percentage distributions, Kruskal Wallis, Mann Withney-U, Wilcoxon Analysis, Chi-Square test were used.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey
    • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:• Patients on mechanical ventilator who have been in intensive care for at least 48 hours

• Male and female patients over the age of 18
• Patients without thrombocytopenia, leukopenia and oral stomatitis, aphthae, candiasis, gingivitis
• Patients whose respiratory support is provided by a mechanical ventilator
• Patients who are considered to be able to provide mechanical ventilator support for 7 days
• Patients without any respiratory-related infectious pathogens
• Obtaining informed consent from the patient if he/she can give consent or from his/her guardian if he/she is unable to give consent.
• It was determined as patients who did not undergo any intraoral surgical intervention.

Exclusion Criteria: patients with pneumonia Patients younger than 18 years

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: One group received standard oral care.	Combination product: One group received standard oral care.; the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.; Combination product: It was applied to the other group by aspiration.; the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
PLACEBO_COMPARATOR: It was applied to the other group by aspiration.	Combination product: One group received standard oral care.; the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.; Combination product: It was applied to the other group by aspiration.; the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral care application with standard oral care stick	Administered with chlorhexidine gluconate solution.	1 in 6 hours
Oral care application with a sucking oral care stick	Administered with chlorhexidine gluconate solution.	1 in 6 hours

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): January 23, 2020
• Study Completion (ACTUAL): February 5, 2020

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 5, 2021
• First Posted (ACTUAL): December 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 5, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: nursing; pneumonia; Mechanical ventilation; oral care
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: AtaturkU-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No