Develop an Oral Care Plan and Verify itNCT07690475
Development and Application of an Oral Care Protocol for Stroke Patients With Orotracheal Intubation
A study testing Standardized oral care protocol and Regular oral care in people with Develop an Oral Care Plan and Verify it, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
Develop a standardized oral care protocol for stroke patients undergoing orotracheal intubation based on evidence-based practice, and validate its effectiveness through clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Develop an Oral Care Plan and Verify it
- What is being tested?
- Standardized oral care protocol and Regular oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed as a patient with stroke;Maintaining an oral tracheal tube insertion;The indwelling time of the oral tracheal tube should be at least 7 consecutive days;No oral diseases before intubation;Tooth count ≥ 10
- Exclusion Criteria:The patient had been intubated for more than 48 hours before admission;Patients who have had their endotracheal tubes replaced during the procedure;Patients who were discharged halfway through their treatment
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Develop a standardized oral care protocol for stroke patients undergoing orotracheal intubation based on evidence-based practice, and validate its effectiveness through clinical trials.
- Conditions
- Develop an Oral Care Plan and Verify it
- Being tested
- Standardized oral care protocol, Regular oral care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized oral care protocolOther
Carry out oral care using the constructed standardized oral care plan
Regular oral careOther
Carry out oral care using conventional methods
| Study group | Role | What they receive |
|---|---|---|
| Standardized oral care | Experimental | Patients in this group will receive the standardized oral care protocol developed for post-intubation stroke patients. The intervention includes using [填入具体溶液，如 0.12% Chlorhexidine] solution, performed every 6 hours by trained nurses, following a specific assessment checklist to ensure thorough cleaning of the oral cavity and prevention of VAP. Receives: Other: Standardized oral care protocol |
| Regular oral care | Active comparator | Patients in this group will receive the routine oral care procedures currently used in the department. This typically involves basic oral hygiene maintenance according to standard nursing guidelines without the specific standardized protocol interventions applied in the experimental group. Receives: Other: Regular oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventilator-Associated Pneumonia (VAP)
The incidence of VAP will be assessed and compared between the two groups. Diagnosis will be based on clinical criteria including new or progressive radiographic infiltrates, purulent secretions, fever, and leukocytosis.
Measured: From intubation until extubation or discharge from ICU, up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Develop an Oral Care Plan and Verify itStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690475
- Sponsor's protocol ID
- KY-2026-099
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of an Oral Care Protocol for Stroke Patients With Orotracheal Intubation
- ClinicalTrials.gov ID
- NCT07690475
- Acronym / sponsor ID
- KY-2026-099
- Conditions
- Develop an Oral Care Plan and Verify it
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 8 Jul 2026 (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.
Develop a standardized oral care protocol for stroke patients undergoing orotracheal intubation based on evidence-based practice, and validate its effectiveness through clinical trials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized oral care | Experimental | Other: Standardized oral care protocolPatients in this group will receive the standardized oral care protocol developed for post-intubation stroke patients. The intervention includes using [填入具体溶液，如 0.12% Chlorhexidine] solution, performed every 6 hours by trained nurses, following a specific assessment checklist to ensure thorough cleaning of the oral cavity and prevention of VAP. |
| Regular oral care | Active comparator | Other: Regular oral carePatients in this group will receive the routine oral care procedures currently used in the department. This typically involves basic oral hygiene maintenance according to standard nursing guidelines without the specific standardized protocol interventions applied in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as a patient with stroke;Maintaining an oral tracheal tube insertion;The indwelling time of the oral tracheal tube should be at least 7 consecutive days;No oral diseases before intubation;Tooth count ≥ 10
- Exclusion Criteria:The patient had been intubated for more than 48 hours before admission;Patients who have had their endotracheal tubes replaced during the procedure;Patients who were discharged halfway through their treatment
- -
Key exclusion criteria (0 listed)
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 protocolCarry out oral care using the constructed standardized oral care plan | Other | Standardized oral care |
| Regular oral careCarry out oral care using conventional methods | Other | Regular oral care |
Primary outcome
Incidence of Ventilator-Associated Pneumonia (VAP)
Time frame: From intubation until extubation or discharge from ICU, up to 28 days.
The incidence of VAP will be assessed and compared between the two groups. Diagnosis will be based on clinical criteria including new or progressive radiographic infiltrates, purulent secretions, fever, and leukocytosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized oral care protocol and Regular oral care in people with Develop an Oral Care Plan and Verify it, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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 3 inclusion and 0 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: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tu HJ juan (+86 1886759508, 1240435911@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ventilator-Associated Pneumonia (VAP) (time frame: From intubation until extubation or discharge from ICU, up to 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.