Study on 3D-Printed Artificial Airway Fixation Device for Obese Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Endotracheal Tube Displacement or Dislodgement Grade
研究概览
简要总结
This study is looking for a better way to secure breathing tubes for obese patients who need them. For patients with obesity, a short neck and extra tissue can make it difficult to keep a breathing tube in the correct position. When a tube moves, it can cause serious problems.
Researchers want to compare a new, personalized breathing tube holder with the standard methods currently used.
Participants in this study will be randomly assigned to one of two groups: The Intervention Group will use a new tube holder made with a 3D printer. This holder is custom-designed to fit the specific shape of the patient's face. The Control Group will use the standard methods to secure the breathing tube, such as a conventional holder or medical tape.
Researchers will check things like how well the tube stays in place, the condition of the patient's skin around the mouth, and the comfort of the patient. The goal is to see if the new 3D-printed device is safer, more secure, and more comfortable for obese patients with a breathing tube. The study will include 66 adult patients who are obese and require a breathing tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •Meets indications for endotracheal intubation.
- •Body Mass Index (BMI) ≥28 kg/m².
- •Intact skin around the mouth, cheeks, and neck without lesions before endotracheal intubation.
- •Estimated intubation time >12 hours.
- •The patient or their family understands and voluntarily participates in this study, and signs the informed consent form.
排除标准
- •Patients with a history of psychiatric diagnosis.
- •Patients with laryngeal injury.
- •Patients with oral diseases or facial skin damage.
- •Patients who have undergone intubation more than once during the current hospitalization.
研究组 & 干预措施
Conventional Fixation Methods
For Orotracheally Intubated Patients: The standard method involves passing the endotracheal tube through a conventional fixer, tightening the screw cap, and fastening a strap around the neck.
干预措施: Conventional Fixation Methods (Other)
3D-Printed Personalized Fixation Device
This arm uses a personalized artificial airway fixation device for obese patients, developed with 3D printing technology, to secure the endotracheal tube.
干预措施: 3D-Printed Personalized Artificial Airway Fixation Device (Device)
结局指标
主要结局
Endotracheal Tube Displacement or Dislodgement Grade
时间窗: From intubation through extubation, an average of 7 days.
The stability of the endotracheal tube is assessed using a 5-point grading scale. Grade 1: No displacement. Grade 2: Mild displacement (change of \<1 cm). Grade 3: Moderate displacement (change of 1-2 cm). Grade 4: Severe displacement (change of \>2 cm). Grade 5: Unplanned extubation (tube is completely dislodged).
Local Skin Integrity
时间窗: Daily from intubation through extubation, up to 14 days.
The contact area was inspected daily and recorded for skin irritation or allergic reaction, categorized as "Yes" or "No".
Airway Management Safety Indicators
时间窗: Average of measurements taken during each oral care procedure from intubation through extubation (an average of 7 days)
Safety indicators are measured during each nursing procedure (oral care and replacement of the fixation device), including: ①Irritative Cough Duration: The duration (in seconds) of a patient's continuous coughing or choking is recorded. ②Heart Rate and SpO₂ Fluctuation: Heart rate (beats/minute) and peripheral oxygen saturation (SpO₂) are monitored and recorded before and after each procedure to assess changes.
次要结局
未报告次要终点