Stroke, IschemicNCT05521659
Oral Care in Non-Mechanically Ventilated Stroke Patients
A study testing Standardized oral care protocol in people with Stroke, Ischemic, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Standardized oral care protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who were intubated or tracheostomized were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Bakırköy Prof. Dr. Mazhar Osman Ruh Sağlığı ve Sinir Hastalıkları Eğitim ve Araştırma Hastanesi /
Istanbul
About this study
Official title: A Systematic Oral Care Protocol in Non-Mechanically Ventilated Stroke Patients
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.
Read the 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.
- Conditions
- Stroke, Ischemic
- Being tested
- Standardized oral care protocol
- Keywords
- oral care, stroke, oral mucosa, colonization, bacteria
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized oral care protocolOther
Standardized oral care protocol (3 times a day at certain hours (06-14-22) with oral care set including chlorhexidine gluconate)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Evaluation will be done at the beginning of the study and at the end of the 5th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Bakirkoy Prof. Dr. Mazhar Osman Hospital for Psychiatry, Neurology and Neurosurgery
- Responsible party
- Principal investigator, Zeliha Tülek, Istanbul University - Cerrahpasa
- Investigators
- Zeliha Tülek, RN, PhD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521659
- Sponsor's protocol ID
- Oral Care in Stroke
- Status last verified
- Aug 2022
- First submitted
- 11 Jan 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26765505Emery 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.
PubMed 30793402
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Oral Care Protocol in Non-Mechanically Ventilated Stroke Patients
- ClinicalTrials.gov ID
- NCT05521659
- Acronym / sponsor ID
- Oral Care in Stroke
- Conditions
- Stroke, Ischemic
- Keywords
- oral care, stroke, oral mucosa, colonization, bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Bakirkoy Prof. Dr. Mazhar Osman Hospital for Psychiatry, Neurology and Neurosurgery
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized oral care protocol | Experimental | Other: Standardized oral care protocolIntervention: 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. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who were intubated or tracheostomized were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized oral care protocolStandardized oral care protocol (3 times a day at certain hours (06-14-22) with oral care set including chlorhexidine gluconate) | Other | Standardized oral care protocol |
Primary outcome
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.
2 secondary outcomes
the type of bacteria variable
Time frame: Evaluation will be done at the beginning of the study and at the end of the 5th day.
oral evaluation scale variable
Time frame: Evaluation will be done at the beginning of the study and at the end of the 5th day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 26765505Chipps 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.
- Background: PubMed 30793402Emery 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha Tülek, RN, PhD study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized oral care protocol in people with Stroke, Ischemic, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of bacteria variable (time frame: 5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.