Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

May 21, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wang Li Zhu, Master
  • Phone Number: +86 0571 87767013
  • Email: zrwlz@zju.edu.cn

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ICU patient with tracheal intubation inserted through the mouth

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Zhu Yi Rong, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
  • Principal Investigator: Sun Yan, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
  • Principal Investigator: Xiang Yan, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
  • Principal Investigator: Guo Jingjing, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0586

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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