Oral Mucosal Pressure InjuryNCT05882539
Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation
An observational study of Oral Mucosal Pressure Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucosal Pressure Injury
- What is being tested?
- endotracheal tube material,Bite block Material
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 471 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Dec 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patient with tracheal intubation inserted through the mouth
Who may be able to join
- Age ≥ 18 years;
- Duration of ICU admission ≥ 48h.
Who cannot join
- radiotherapy oral mucositis;
- Pressure injury to the mucosa, oral ulcers and erosions from other causes already present prior to tracheal intubation;
- Patients undergoing oral surgery;
- those who have been brought in from outside the hospital for >48h for transoral tracheal intubation;
- Common oral ulcers (not pressure/friction generated).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Chen Ze Xin, +86 0571 87783759, keyanlunli_zheer@163.com
About this study
Official title: 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.
- Conditions
- Oral Mucosal Pressure Injury
- Being tested
- endotracheal tube material,Bite block Material
- Keywords
- Intensive Care Units, Intubation, Intratracheal, Mucosal Pressure Injury, Prediction Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tube material,Bite block MaterialDevice
Also called Moisture of oral mucosa, serum albumin level, mean arterial pressure level, blood lactate level
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.
| Study group | Role | What they receive |
|---|---|---|
| endotracheal tube material | One group of patients used a spring-loaded endotracheal tube and the other group used a PVC tube. Receives: Device: endotracheal tube material,Bite block Material | |
| Bite block Material | One group of patients used hard bite block and the other group used soft bite block Receives: Device: endotracheal tube material,Bite block Material | |
| Moisture of oral mucosa | One group of patients had moist oral mucosa after entering the ward and the other group had dry oral mucosa. Receives: Device: endotracheal tube material,Bite block Material | |
| 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. Receives: Device: endotracheal tube material,Bite block Material | |
| mean arterial pressure level | One group of patients had normal mean arterial pressure leve after entering the ward and the other group was abnormal. Receives: Device: endotracheal tube material,Bite block Material | |
| 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. Receives: Device: endotracheal tube material,Bite block Material | |
| constraint | One group of patients was constrained during follow-up and the other group was not constrained. Receives: Device: endotracheal tube material,Bite block Material | |
| sedation | One group of patients was sedated during follow-up and the other group was not sedated. Receives: Device: endotracheal tube material,Bite block Material | |
| prone position | One group of patients had a prone position performed during follow-up and the other group did not. Receives: Device: endotracheal tube material,Bite block Material | |
| Duration of tracheal intubation | Dichotomous grouping of the duration of tracheal intubation according to the results of the study. Receives: Device: endotracheal tube material,Bite block Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral mucosal pressure injury
Whether oral mucosal pressure injury occurred during the follow-up period
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jan 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucosal Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 471 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhu Yi Rong, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaSun Yan, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaXiang Yan, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaGuo Jingjing, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882539
- Sponsor's protocol ID
- 2022-0586
- Status last verified
- May 2023
- First submitted
- 21 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Risk Prediction Model for Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation
- ClinicalTrials.gov ID
- NCT05882539
- Acronym / sponsor ID
- 2022-0586
- Conditions
- Oral Mucosal Pressure Injury
- Keywords
- Intensive Care Units, Intubation, Intratracheal, Mucosal Pressure Injury, Prediction Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 471 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| endotracheal tube material | – | Device: endotracheal tube material,Bite block MaterialOne group of patients used a spring-loaded endotracheal tube and the other group used a PVC tube. |
| Bite block Material | – | Device: endotracheal tube material,Bite block MaterialOne group of patients used hard bite block and the other group used soft bite block |
| Moisture of oral mucosa | – | Device: endotracheal tube material,Bite block MaterialOne group of patients had moist oral mucosa after entering the ward and the other group had dry oral mucosa. |
| serum albumin level | – | Device: endotracheal tube material,Bite block MaterialOne 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 | – | Device: endotracheal tube material,Bite block MaterialOne group of patients had normal mean arterial pressure leve after entering the ward and the other group was abnormal. |
| blood lactate level | – | Device: endotracheal tube material,Bite block MaterialOne group of patients had normal blood lactate levels at the first blood sample analysis after tracheal intubation and the other group was abnormal. |
| constraint | – | Device: endotracheal tube material,Bite block MaterialOne group of patients was constrained during follow-up and the other group was not constrained. |
| sedation | – | Device: endotracheal tube material,Bite block MaterialOne group of patients was sedated during follow-up and the other group was not sedated. |
| prone position | – | Device: endotracheal tube material,Bite block MaterialOne group of patients had a prone position performed during follow-up and the other group did not. |
| Duration of tracheal intubation | – | Device: endotracheal tube material,Bite block MaterialDichotomous grouping of the duration of tracheal intubation according to the results of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patient with tracheal intubation inserted through the mouth
Key inclusion criteria (2 listed)
- Age ≥ 18 years;
- Duration of ICU admission ≥ 48h.
Key exclusion criteria (5 listed)
- radiotherapy oral mucositis;
- Pressure injury to the mucosa, oral ulcers and erosions from other causes already present prior to tracheal intubation;
- Patients undergoing oral surgery;
- those who have been brought in from outside the hospital for >48h for transoral tracheal intubation;
- Common oral ulcers (not pressure/friction generated).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal tube material,Bite block MaterialAlso: Moisture of oral mucosa, serum albumin level, mean arterial pressure level, blood lactate levelExposure 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. | Device | Bite block Material, Duration of tracheal intubation, Moisture of oral mucosa, blood lactate level, constraint, endotracheal tube material, mean arterial pressure level, prone position, sedation, serum albumin level |
Primary outcome
oral mucosal pressure injury
Time frame: up to 2 weeks
Whether oral mucosal pressure injury occurred during the follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Related trials for Oral Mucosal Pressure Injury
Not yet recruiting
EFFECT OF A NURSING CARE BUNDLE ON MEDICAL DEVICE-RELATED ORAL MUCOSAL MEMBRANE PRESSURE INJURIES IN INTENSIVE CARE PATIENTS
Oral Mucosal Membrane Pressure Injury
Not yet recruiting
The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries
Mucosal Wound, Mucosal Erosion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhu Yi Rong study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Sun Yan principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Xiang Yan principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Mucosal Pressure Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Qian, Master (+86 0571 87767013, 2515210@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral mucosal pressure injury (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.