Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

Recruiting

• Conditions: Oral Mucosal Pressure Injury
• Interventions: Device: endotracheal tube material,Bite block Material

• Registration Number: NCT05882539
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-21
• Study First Submitted QC: 2023-05-21
• Last Update Submitted: 2023-05-21
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 471

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moisture of oral mucosa	endotracheal tube material,Bite block Material	One group of patients had moist oral mucosa after entering the ward and the other group had dry oral mucosa.
endotracheal tube material	endotracheal tube material,Bite block Material	One group of patients used a spring-loaded endotracheal tube and the other group used a PVC tube.
blood lactate level	endotracheal tube material,Bite block Material	One group of patients had normal blood lactate levels at the first blood sample analysis after tracheal intubation and the other group was abnormal.
Bite block Material	endotracheal tube material,Bite block Material	One group of patients used hard bite block and the other group used soft bite block
serum albumin level	endotracheal tube material,Bite block Material	One group of patients had normal serum albumin level at the first blood sample analysis after tracheal intubation and the other group was abnormal.
mean arterial pressure level	endotracheal tube material,Bite block Material	One group of patients had normal mean arterial pressure leve after entering the ward and the other group was abnormal.
sedation	endotracheal tube material,Bite block Material	One group of patients was sedated during follow-up and the other group was not sedated.
constraint	endotracheal tube material,Bite block Material	One group of patients was constrained during follow-up and the other group was not constrained.
prone position	endotracheal tube material,Bite block Material	One group of patients had a prone position performed during follow-up and the other group did not.
Duration of tracheal intubation	endotracheal tube material,Bite block Material	Dichotomous grouping of the duration of tracheal intubation according to the results of the study.

Primary Outcome Measures

Name	Time	Method
oral mucosal pressure injury	up to 2 weeks	Whether oral mucosal pressure injury occurred during the follow-up period

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China