Automated Versus Manual Cuff Pressure Control for Preventing Microaspiration With TaperGuard Endotracheal Tubes in Elective Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Penetration of blue-dyed oropharyngeal secretions into the distal airway
研究概览
简要总结
The goal of this clinical trial is to learn if a new method for managing breathing tube pressure is better at preventing fluid from leaking into patients' lungs during surgery. It will also check if it causes fewer side effects like a sore throat.
The main questions it aims to answer are:
Does using a continuous pressure controller reduce fluid leakage past the breathing tube cuff compared to the standard manual method? Does the continuous pressure controller lead to fewer and less severe sore throats and voice changes after surgery?
Researchers will compare two groups:
Group 1: Patients whose breathing tube cuff pressure is managed with a continuous automatic controller.
Group 2: Patients whose breathing tube cuff pressure is managed with the standard manual method.
Participants will:
Be randomly assigned to one of the two groups before their surgery. Receive a small, safe amount of blue dye in their mouth during the procedure to help measure leakage.
Have two small secretion samples collected from their breathing tube during surgery.
Be asked about sore throat and voice changes at 1, 2, 3, and 24 hours after the breathing tube is removed.
详细描述
- The Clinical Challenge: Microaspiration and the Breathing Tube
Endotracheal intubation is a life-saving procedure, but it inherently bypasses the body's natural defenses against lung infection. A critical, yet often overlooked, problem is microaspiration. This is the silent leakage of small amounts of oropharyngeal secretions past the cuff of the breathing tube and into the lower airways and lungs. This phenomenon is a primary contributor to the development of Ventilator-Associated Pneumonia (VAP), a serious complication that increases patient morbidity, mortality, and healthcare costs.
The cuff's primary role is to create a seal within the trachea. However, conventional cylindrical cuffs can form folds or channels when inflated, creating a direct pathway for secretions to leak through. Furthermore, maintaining the correct cuff pressure (recommended 25-30 cmH₂O) is challenging; pressure can fluctuate due to patient movement, changes in anesthesia gas volume, and surgical positioning. 2. Technological Innovations and the Evidence Gap
To address these issues, manufacturers have developed advanced endotracheal tubes. This study focuses on the TaperGuard™ Evac tube (Covidien/Medtronic), which features a uniquely shaped tapered cuff. This design is intended to inflate more uniformly against the tracheal wall, theoretically reducing the formation of leakage channels compared to traditional cylindrical cuffs.
Concurrently, technology for pressure management has evolved. While the current standard of care involves intermittent manual checks with a manometer, automated cuff pressure controllers (like the Pressure Easy® device) have been introduced. These devices continuously monitor and adjust the pressure, maintaining it within a pre-set target range throughout the entire procedure without manual intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
盲法说明
In addition to the participants, both the investigator responsible for patient randomization and the evaluator analyzing the samples for microaspiration will be blinded to group allocation. This double-masking approach is intended to minimize bias in both the allocation process and the outcome assessment.
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
- •Adult patients (>18 years old) scheduled for surgery lasting at least one hour.
- •ASA I-III classification.
- •Signed informed consent.
排除标准
- •Pre-existing airway pathology (e.g., tracheomalacia, granulomas, stenosis, tumors).
- •Anticipated difficult intubation (Macocha Score > 3 points).
- •Selective lung ventilation / one-lung ventilation.
- •Current participation in another clinical trial.
- •Elimination Criteria:
- •Accidental extubation.
- •Cardiorespiratory arrest or death.
结局指标
主要结局
Penetration of blue-dyed oropharyngeal secretions into the distal airway
时间窗: From enrollment to the end of Surgery: Tracheal aspirate samples will be collected at two defined time points: the first between 10 and 30 minutes after intubation and hemodynamic stabilization, and the second immediately prior to extubation.
Evaluate the penetration of blue-dyed oropharyngeal secretions into the distal airway in patients undergoing orotracheal intubation.
次要结局
- Determine the incidence of post-extubation pain.(The pain will be assessed at the following post-extubation time points: 1 hour, 2 hours, 3 hours, and 24 hours.)
- Determine the incidence of post-extubation dysphonia.(These dysphonia will be assessed at the following post-extubation time points: 1 hour, 2 hours, 3 hours, and 24 hours.)
- Real-time changes in endotracheal tube cuff pressure during the surgical procedure(Intraoperative ( surgical procedure))
- Determine the incidence of post-extubation pain.(The pain will be assessed at the following post-extubation time points: 1 hour, 2 hours, 3 hours, and 24 hours.)
- Determine the incidence of post-extubation dysphonia.(These dysphonia will be assessed at the following post-extubation time points: 1 hour, 2 hours, 3 hours, and 24 hours.)
研究者
Gustavo Plotnikow
Head of Physical and Respiratory Care Department, ICU
HOSPITAL BRITANICO DE BUENOS AIRES