Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

Construction of Risk Prediction Model for Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05882539

Enrollment

471

Registered

2023-05-31

Start date

2023-01-01

Completion date

2024-12-30

Last updated

2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Mucosal Pressure Injury

Keywords

Intensive Care Units, Intubation, Intratracheal, Mucosal Pressure Injury, Prediction Model

Brief summary

In this study, based on the conceptual framework of Pressure Injurie development, the risk factors for pressure injury in critically ill patients provided by the latest guidelines, and combined with the current relevant studies on mucosal pressure injury, we prospectively observed and collected clinical data related to tracheal intubation patients in the ICU, analyzed the risk factors for the occurrence of oral MPI, and established a risk prediction model to help clinical and nursing staff to detect and actively prevent oral MPI at an early stage The study aims to improve the quality of nursing management, enhance the level of nursing services and improve patient satisfaction.

Interventions

DEVICEendotracheal tube material,Bite block Material

Exposure factors associated with tracheal intubation in patients that may influence the occurrence of oral mucosa pressure injurie, such as the material and fixation of the tracheal tube, the patient's own nutrition, the level of tissue perfusion and relevant treatment factors.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years; 2. Duration of ICU admission ≥ 48h.

Exclusion criteria

1. radiotherapy oral mucositis; 2. Pressure injury to the mucosa, oral ulcers and erosions from other causes already present prior to tracheal intubation; 3. Patients undergoing oral surgery; 4. those who have been brought in from outside the hospital for \>48h for transoral tracheal intubation; 5. Common oral ulcers (not pressure/friction generated).

Design outcomes

Primary

Measure	Time frame	Description
oral mucosal pressure injury	up to 2 weeks	Whether oral mucosal pressure injury occurred during the follow-up period

Countries

China

Contacts

Primary ContactLi Qian, Master

2515210@zju.edu.cn+86 0571 87767013

Backup ContactWang Li Zhu, Master

zrwlz@zju.edu.cn+86 0571 87767013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026