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Clinical Trials/NCT05521659
NCT05521659
Completed
Not Applicable

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

Istanbul University - Cerrahpasa (IUC)1 site in 1 country42 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
42
Locations
1
Primary Endpoint
the number of bacteria variable
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
June 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Zeliha Tülek

Assoc.Prof

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the number of bacteria variable

Time Frame: 5 days.

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.

Secondary Outcomes

  • oral evaluation scale variable(Evaluation will be done at the beginning of the study and at the end of the 5th day.)
  • the type of bacteria variable(Evaluation will be done at the beginning of the study and at the end of the 5th day.)

Study Sites (1)

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