Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

Zhejiang University

Status: Enrolling

Conditions: Oral Mucosal Pressure Injury

Treatments: Device: endotracheal tube material,Bite block Material

Study type: Observational

Funder types: Other

Identifiers

NCT05882539

2022-0586

Details and patient eligibility

About

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.

Enrollment: 471 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

471 participants in 10 patient groups

endotracheal tube material

Description:

One group of patients used a spring-loaded endotracheal tube and the other group used a PVC tube.

Treatment:

Device: endotracheal tube material,Bite block Material

Bite block Material

Description:

One group of patients used hard bite block and the other group used soft bite block

Treatment:

Device: endotracheal tube material,Bite block Material

Moisture of oral mucosa

Description:

One group of patients had moist oral mucosa after entering the ward and the other group had dry oral mucosa.

Treatment:

Device: endotracheal tube material,Bite block Material

serum albumin level

Description:

One group of patients had normal serum albumin level at the first blood sample analysis after tracheal intubation and the other group was abnormal.

Treatment:

Device: endotracheal tube material,Bite block Material

mean arterial pressure level

Description:

One group of patients had normal mean arterial pressure leve after entering the ward and the other group was abnormal.

Treatment:

Device: endotracheal tube material,Bite block Material

blood lactate level

Description:

One group of patients had normal blood lactate levels at the first blood sample analysis after tracheal intubation and the other group was abnormal.

Treatment:

Device: endotracheal tube material,Bite block Material

constraint

Description:

One group of patients was constrained during follow-up and the other group was not constrained.

Treatment:

Device: endotracheal tube material,Bite block Material

sedation

Description:

One group of patients was sedated during follow-up and the other group was not sedated.

Treatment:

Device: endotracheal tube material,Bite block Material

prone position

Description:

One group of patients had a prone position performed during follow-up and the other group did not.

Treatment:

Device: endotracheal tube material,Bite block Material

Duration of tracheal intubation

Description:

Dichotomous grouping of the duration of tracheal intubation according to the results of the study.

Treatment:

Device: endotracheal tube material,Bite block Material