Oral Care in Non-Mechanically Ventilated Stroke Patients

Study Overview
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Brief Summary
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This study was conducted to examine the effect of a systematic oral care protocol on bacterial colonization of the oral mucosa in non-mechanically ventilated stroke patients. This experimental study was conducted in Bakirkoy Prof. Dr. Mazhar Osman Research and Training Hospital for Psychiatry, Neurology and Neurosurgery between January -June 2020. The research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. A standardized oral care protocol was developed and applied to the patients in the experimental group three times a day. The control group underwent non-standardized oral care, which is available in the routine practice of the clinic. Two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity and complications.

Detailed Description
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This experimental study was conducted in Bakirkoy Prof. Dr. Mazhar Osman Research and Training Hospital for Psychiatry, Neurology and Neurosurgery between January -June 2020. The research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. A standardized oral care protocol was developed and applied to the patients in the experimental group three times (at 06:00, 14:00, 22:00) a day (with use of an oral hygiene kit including chlorhexidin gluconate). The control group underwent usual care (oral care with use of the same kit but applied twice a day without following a protocol). Two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity (by use of Oral Assessment Guide) and complications.

Official Title
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A Systematic Oral Care Protocol in Non-Mechanically Ventilated Stroke Patients

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Other: Standardized oral care protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a diagnosis of stroke, Being not connected to a mechanical ventilator (patients who were on spontaneous breathing or receiving oxygen support with a mask or nasal cannula), Having at least 3 teeth, and Cannot meet the need for oral care. Exclusion Criteria: Patients who were intubated or tracheostomized were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized oral care protocol<br>Intervention: Patients in experimental group were given oral care 3 times a day at certain hours (06-14-22) with oral care set including chlorhexidine gluconate. | Other: Standardized oral care protocol<br>* Standardized oral care protocol (3 times a day at certain hours (06-14-22) with oral care set including chlorhexidine gluconate)<br>|
| No Intervention: Control Group<br>Routine oral care (usual oral care with the same appliances and solution but applied twice a day without following a protocol) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of bacteria variable | The number of bacteria in the oral mucosa of stroke patients who are given oral care according to the standardized oral care protocol after the intervention will be less than the pre-intervention and control groups. | 5 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the type of bacteria variable | The type of bacteria in the oral mucosa of stroke patients who are given oral care according to the standardized oral care protocol after the intervention will be less than the pre-intervention and control groups. | Evaluation will be done at the beginning of the study and at the end of the 5th day. | 
| oral evaluation scale variable | The mean Oral Evaluation Scale score of stroke patients who are given oral care according to the standard oral care protocol after the intervention will be lower than the pre-intervention and control groups. | Evaluation will be done at the beginning of the study and at the end of the 5th day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral care, stroke, oral mucosa, colonization, bacteria