Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Presence of Tracheal Injury Symptoms (Composite Outcome).
研究概览
简要总结
This prospective observational study aims to identify risk factors for tracheal mucosal injuries caused by orotracheal tube use during the intraoperative period in patients undergoing elective surgeries at the Hospital de Clínicas de Porto Alegre. The study will recruit patients sequentially for elective procedures requiring general anesthesia and orotracheal intubation. Primary outcomes include symptoms such as hoarseness, pharyngolaryngeal pain, cough, and hemoptysis, assessed up to 30 days post-surgery. A risk score for tracheal injuries will be derived.
详细描述
Orotracheal tubes are widely used in medical practice to secure the airway and enable invasive mechanical ventilation. Modern tubes are made of medical-grade PVC with an inflatable cuff at the distal end to isolate the lower airway, prevent gas leaks from ventilation, and reduce contamination risks from upper airway secretions or gastric content. Although current cuffs are high-volume, low-pressure, overinflation complications are common, leading to variable severity lesions (isolated or confluent lesions, tracheal mucosal edema, erosions, or ulcerations with bleeding), and symptoms like dysphonia/aphonia (15-80%), cough, pain, and hemoptysis (10-15%). Overinflation can compromise tracheal mucosal perfusion, causing ischemia, necrosis, tracheoesophageal fistulas, or tracheal rupture, especially in patients requiring prolonged intubation. Even short exposures (hours) can cause significant lesions. Many physicians rely on manual palpation or experience to set cuff pressure, often inaccurately. This study will evaluate risk factors in elective surgical patients at HCPA, using multivariate regression to identify independent variables and derive a risk score.
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
- •Age greater than 18 years.
- •Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
排除标准
- •Age less than 18 years.
- •Refusal to participate in the study.
- •Surgeries performed on an urgent or emergency basis.
- •Surgeries in pregnant women.
- •Cardiac surgeries.
- •Surgeries requiring single-lung ventilation.
- •Head and neck surgeries.
- •Surgeries on the cervical segment of the dorsal spine.
- •Surgeries requiring lateral or prone positioning.
- •Anticipated difficult airway (unanticipated difficult airways will be included).
- •Insufficient fasting time.
- •Surgeries in patients admitted to intensive care units.
- •Patients presenting the same symptoms included in the outcomes to be measured (pre-existing hoarseness, pain, cough, hemoptysis).
- •Tracheostomized patients or those with previous tracheobronchial segment lesions.
研究组 & 干预措施
Single Group - Elective Surgical Patients
Single Group - Elective Surgical Patients (All patients undergoing elective surgeries with general anesthesia and orotracheal intubation; no arms as it is observational).
结局指标
主要结局
Presence of Tracheal Injury Symptoms (Composite Outcome).
时间窗: First 24 hours post-op to 30 days post-op
Composite of hoarseness, pharyngolaryngeal pain, cough, and hemoptysis related to orotracheal tube use during surgery. Hoarseness, pain, and cough assessed via verbal numerical scale (0 = absent, 10 = worst possible). Hemoptysis assessed as present/absent, and volume (\>100 ml/24h considered massive).
次要结局
- Independent Variables for Tracheal Complications.(Intraoperative and up to 30 days post-op.)
研究者
Andre Prato Schmidt
MD, PhD
Hospital de Clinicas de Porto Alegre