Effectiveness of Detachment of the Breathing Circuit on the Rate of the Double-lumen Endotracheal Tube Malposition After the Change of Position in Patients Undergoing Thoracic Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 256
- 主要终点
- Malposition rate of a double-lumen endobronchial tube
研究概览
简要总结
The goal of this clinical trial is to assess the incidence of double-lumen endobronchial tube displacement in patients undergoing thoracic surgery with a change in position, compared with double-lumen endobronchial tube malposition in chest surgery patients with a fixed breathing circuit. The study is to investigate: whether detaching the breathing circuit in patients undergoing thoracic surgery would reduce the rate of double-lumen endobronchial tube malposition, the incidence of postoperative pulmonary complications, and improve patient outcomes.
Participants will be randomly divided into a disconnected breathing circuit group and a breathing circuit connected group and after entering the operating room, the intravenous access will be opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation, arterial pressure, and end-expiratory carbon dioxide will be monitored. Anesthesia induction will be performed by an anesthesiologist, and then the double-lumen endobronchial tube will be inserted under laryngoscopic guidance. Will the catheter be delivered to the expected depth, the double-lumen endobronchial tube will be connected to the anesthesia machine for mechanical ventilation.
Researchers will compare the malposition rate of the double-lumen endobronchial tube when the patient transitions from the supine to lateral decubitus position, the effect of single-lung ventilation, oxygen saturation at 5 and 10 minutes after single-lung ventilation, and postoperative recovery time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
As this research uses a behavioral intervention, it will conceal the grouping from the subjects. Random numbers will be placed in opaque envelopes by independent persons not involved in this experiment to achieve allocation concealment.
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
- •ASA I-II elective surgery for patients
- •Patients undergoing thoracic surgery requiring a left-sided double-lumen endobronchial tube;
- •Sign the informed consent form for this clinical study.
排除标准
- •Mouth opening <3cm;
- •History of previous difficult intubation;
- •Patients with diseases of the upper respiratory tract and main bronchi;
- •Cardiac insufficiency;
- •People with liver dysfunction;
- •Renal insufficiency;
- •Previous stroke;
- •Patients with severe obstructive ventilation dysfunction;
- •Bronchial asthma or airway hyperresponsiveness;
- •Patients who have participated in other clinical studies in the past 3 months.
结局指标
主要结局
Malposition rate of a double-lumen endobronchial tube
时间窗: Immediately after a change in body position
Double-lumen endobronchial tube malposition is more than 5 mm away from the optimal position of the catheter. Severe malposition is the inability to see the upper left or lower left bronchial opening in the left common bronchi: the right upper lobe bronchial opening cannot be seen clearly in the right common bronchi; or bronchial cuffs more than 50% in the trachea.
次要结局
- PACU length of stay(The time from the transfer to the PACU to the transfer out to ward, an average of an hour)
- Effects of lung collapse(5 and 10 minutes after the pleura opens)
- Blood oxygen saturation(1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation)
研究者
Meng Lv
Deputy Chief Physician
Shandong Provincial Hospital