Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Metrological performance of the Mouth Assessment Tool (MAT)
研究概览
简要总结
Oro-tracheal Intubation uses oro-pharyngeal lesions, impacting on the length and quality of the patient's hospital stay.
There are no oral status assessment tools specifically adapted to orally intubated patients.
It is therefore necessary to create a new tool for assessing the condition of the oral cavity, specific to oro-intubated patients in intensive care.
The aim of the protocol is to evaluate the metrological performance of the newly-developed tool for assessing the state of the oral cavity in adult orally intubated intensive care patients.
详细描述
In France, according to the "medicalized information system program" national database, 230,000 adults are admitted to the intensive care unit every year, 40% of them undergoing invasive mechanical ventilation. That's 90,000 patients for whom an Oro-Tracheal Intubation (OTI) tube is inserted through the mouth into the trachea.
OTI causes oro-pharyngeal lesions, impacting on the length and quality of the patient's hospital stay.
As early as 48 hours after admission to intensive care, the patient's oral and dental condition deteriorates. Pressure lesions can occur, with the OTI probe responsible for 22% to 26% of pressure sores related to invasive equipment. Anarchic chewing also causes injuries to lips, tongue, gums, mucosa and teeth.
In time, these injuries can lead to swallowing disorders, a mechanism for feeding and protecting the airways, and impair the patient's quality of life.
Caregivers in intensive care units have developed mouth care protocols to maintain hygiene and comfort, and prevent lesions that can spread from the lips to the trachea during OTI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person aged 18 or over
- •Person hospitalized in an adult intensive care unit for medical, surgical, polyvalent or burns specialties.
- •Person undergoing oro-tracheal intubation.
- •Person affiliated with or benefiting from a social security scheme.
- •Free and informed oral consent of the patient or his/her legal representative
排除标准
- •Person undergoing Limitation or Cessation of Active Therapeutics
- •Person wearing a multi-attachment fixed dental appliance (braces, multi-rings, brackets bonded to teeth)
- •Person with oral damage making it impossible to measure one of the items on the oral cavity assessment tool (e.g.: removal of the tongue, etc.).
- •Patient under protective supervision (safeguard of justice, curatorship, guardianship)
- •Refusal of patient or legal representative to participate
结局指标
主要结局
Metrological performance of the Mouth Assessment Tool (MAT)
时间窗: At inclusion (Day 0)
The general evaluation criterion is the tool's metrological performance according to COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) psychometric criteria.
次要结局
- Content validity of the Mouth Assessment Tool (MAT)(At inclusion (Day 0))
- Construct validity of the Mouth Assessment Tool (MAT)(At inclusion (Day 0))
- Reliability of the Mouth Assessment Tool (MAT)(At inclusion (Day 0))