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

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 Overview

• Status: Not yet recruiting
• Conditions: Develop an Oral Care Plan and Verify it
• Intervention / Treatment: Other: Standardized oral care protocol; Other: Regular oral care

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tu HJ juan; Phone Number: +86 1886759508; Email: 1240435911@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized oral care; 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; Carry out oral care using the constructed standardized oral care plan
Active Comparator: Regular oral care; 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; Carry out oral care using conventional methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KY-2026-099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No