Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05882539
Collaborator
(none)
471
1
24
19.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: endotracheal tube material,Bite block Material

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
471 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Construction of Risk Prediction Model for Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • 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:
  • Moisture of oral mucosa
  • serum albumin level
  • mean arterial pressure level
  • blood lactate level
  • constraint
  • sedation
  • prone position
  • Duration of tracheal intubation
  • Outcome Measures

    Primary Outcome Measures

    1. oral mucosal pressure injury [up to 2 weeks]

      Whether oral mucosal pressure injury occurred during the follow-up period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310009

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05882539
    Other Study ID Numbers:
    • 2022-0586
    First Posted:
    May 31, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 31, 2023