Back to resultsOral Care to Prevent Ventilator-associated Pneumonia
Primary Purpose
Oral Hygiene, Oral Health, Ventilators, Mechanical
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
One group received standard oral care.
It was applied to the other group by aspiration.
Sponsored by
About this trial
This is an interventional prevention trial for Oral Hygiene, Oral Health focused on measuring Mechanical ventilation, nursing, oral care, pneumonia
Eligibility Criteria
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
-
Sites / Locations
- Atatürk University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
One group received standard oral care.
It was applied to the other group by aspiration.
Arm Description
Outcomes
Primary Outcome Measures
oral care application with standard oral care stick
Administered with chlorhexidine gluconate solution.
Oral care application with a sucking oral care stick
Administered with chlorhexidine gluconate solution.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05161962
Brief Title
Oral Care to Prevent Ventilator-associated Pneumonia
Official Title
Investigation of the Effect of Oral Care Given by Two Different Methods in Patients Connected to Mechanical Ventilators on the Development of Ventilator-AssociatedPneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Hygiene, Oral Health, Ventilators, Mechanical
Keywords
Mechanical ventilation, nursing, oral care, pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One group received standard oral care.
Arm Type
Experimental
Arm Title
It was applied to the other group by aspiration.
Arm Type
Placebo Comparator
Intervention Type
Combination Product
Intervention Name(s)
One group received standard oral care.
Intervention Description
the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
Intervention Type
Combination Product
Intervention Name(s)
It was applied to the other group by aspiration.
Intervention Description
the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
Primary Outcome Measure Information:
Title
oral care application with standard oral care stick
Description
Administered with chlorhexidine gluconate solution.
Time Frame
1 in 6 hours
Title
Oral care application with a sucking oral care stick
Description
Administered with chlorhexidine gluconate solution.
Time Frame
1 in 6 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Facility Information:
Facility Name
Atatürk University
City
Erzurum
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Oral Care to Prevent Ventilator-associated Pneumonia
We'll reach out to this number within 24 hrs