Oral Care in Non-Mechanically Ventilated Stroke Patients

NCT05521659 | Completed

• 1 other identifier: Oral Care in Stroke
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

oral care; stroke; oral mucosa; colonization; bacteria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the type of bacteria variable

  Evaluation will be done at the beginning of the study and at the end of the 5th day.

• oral evaluation scale variable

  Evaluation will be done at the beginning of the study and at the end of the 5th day.

Study Arms (2)

Standardized oral care protocol

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Routine oral care (usual oral care with the same appliances and solution but applied twice a day without following a protocol)

Interventions

Standardized oral care protocol OTHER

Standardized oral care protocol (3 times a day at certain hours (06-14-22) with oral care set including chlorhexidine gluconate)

Standardized oral care protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who were intubated or tracheostomized were excluded.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bakirkoy Prof. Dr. Mazhar Osman Hospital for Psychiatry, Neurology and Neurosurgery: collaborator

Study Sites (1)

İstanbul Bakırköy Prof. Dr. Mazhar Osman Ruh Sağlığı ve Sinir Hastalıkları Eğitim ve Araştırma Hastanesi /

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Chipps EM, Carr M, Kearney R, MacDermott J, Von Visger T, Calvitti K, Vermillion B, Weber ML, Newton C, St Clair J, Harper D, Yamokoski T, Belcher M, Ali N, Hoet AE, Van Balen J, Holloman C, Landers T. Outcomes of an Oral Care Protocol in Postmechanically Ventilated Patients. Worldviews Evid Based Nurs. 2016 Apr;13(2):102-11. doi: 10.1111/wvn.12124. Epub 2016 Jan 14.

  PMID: 26765505 BACKGROUND

• Emery KP, Guido-Sanz F. Oral care practices in non-mechanically ventilated intensive care unit patients: An integrative review. J Clin Nurs. 2019 Jul;28(13-14):2462-2471. doi: 10.1111/jocn.14829. Epub 2019 Mar 13.

  PMID: 30793402 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zeliha Tülek, RN, PhD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: August 30, 2022
• Study Start: January 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)