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临床试验/NCT05921656
NCT05921656已完成不适用

Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
Patient airway area

研究概览

简要总结

There are two cases in which the cross-sectional area of the tracheal catheter balloon does not match the cross-sectional area of the patient's airway. If the area of the tracheal catheter balloon is smaller than the cross-sectional area of the patient's airway, the pressure in the balloon reaches 30 cmH2O, and the airway cannot be completely sealed; This will increase the risk of VAP. If the area of the tracheal catheter balloon is significantly larger than the cross-sectional area of the patient's airway, and the pressure in the balloon reaches 30 cmH2O, the airway cannot be effectively sealed; The formation of wrinkles around the airbag also increases the risk of VAP in patients. Therefore, the purpose of this study is to build a risk model of airway leakage of patients' endotracheal tubes, which provides an accurate and objective assessment tool for medical staff, so that medical staff can select the endotracheal tubes purposefully and with emphasis from the beginning of the patients' endotracheal tubes, and reduce the airway leakage or airway mucosal damage of the endotracheal tubes.

详细描述

Admission number, department, name, gender, height, and weight are obtained through the hospital's electronic medical record management system。 Tidal volume (set Tidal volume), airway peak pressure (real-time data on the ventilator screen), data collection is synchronized with the minimum cuff pressure measurement when the airway is closed.

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
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Invasive mechanical ventilation; Chest CT imaging examination within 1 year;

排除标准

  • Patients with pneumothorax Acute respiratory distress syndrome; Chronic Obstructive Pulmonary Disease; Multiple organ dysfunction.

结局指标

主要结局

Patient airway area

时间窗: Within 1 year

Firstly, confirm the front position of the tracheal catheter through chest X-ray, and then manually sketch the area of interest along the outer wall of the airway using Computed Tomography to calculate the area.

次要结局

  • Measure the minimum cuff pressure(1min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Honglei Wu

the investigators

Affiliated Hospital of Nantong University

研究点 (1)

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