Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation
NCT ID: NCT05882539
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
471 participants
OBSERVATIONAL
2023-01-01
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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endotracheal tube material
One group of patients used a spring-loaded endotracheal tube and the other group used a PVC tube.
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.
Bite block Material
One group of patients used hard bite block and the other group used soft bite block
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.
Moisture of oral mucosa
One group of patients had moist oral mucosa after entering the ward and the other group had dry oral mucosa.
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.
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.
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.
mean arterial pressure level
One group of patients had normal mean arterial pressure leve after entering the ward and the other group was abnormal.
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.
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.
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.
constraint
One group of patients was constrained during follow-up and the other group was not constrained.
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.
sedation
One group of patients was sedated during follow-up and the other group was not sedated.
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.
prone position
One group of patients had a prone position performed during follow-up and the other group did not.
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.
Duration of tracheal intubation
Dichotomous grouping of the duration of tracheal intubation according to the results of the study.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Duration of ICU admission ≥ 48h.
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Zhu Yi Rong
Role: STUDY_DIRECTOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Sun Yan
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Xiang Yan
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Guo Jingjing
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Chen Ze Xin
Role: primary
Other Identifiers
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2022-0586
Identifier Type: -
Identifier Source: org_study_id