Development and Application of an Oral Care Protocol for Stroke Patients With Orotracheal Intubation

NCT07690475 | Not Yet Recruiting

• 1 other identifier: KY-2026-099
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Develop an Oral Care Plan and Verify it

Outcome Measures

Primary Outcomes (1)

• 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.

  From intubation until extubation or discharge from ICU, up to 28 days.

Study Arms (2)

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.

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.

Other: Regular oral care

Interventions

Standardized oral care protocol OTHER

Carry out oral care using the constructed standardized oral care plan

Standardized oral care

Regular oral care OTHER

Carry out oral care using conventional methods

Regular oral care

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Central Study Contacts

Tu HJ juan

CONTACT

+86 1886759508; 1240435911@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share