Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Intubation allocation time
研究概览
简要总结
The purpose of this experiment is to verify whether selecting a double-lumen tube one size smaller based on the traditional personalized method can shorten the intubation time without increasing ventilation complications when performing tracheal intubation for thoracic surgery in Asian women.Patients receive double-lumen tubes of a size selected based on the traditional personalized method or one size smaller than that chosen by the traditional method during tracheal intubation. The primary outcome is the time duration required to complete Double-lumen tube intubation and positioning.
详细描述
The selection of double-lumen tube sizes using traditional methods relies on two factors: height and gender. In this study, all patients planned to be enrolled are female, so the traditional corresponding relationship is roughly as follows: For patients with a height of less than 152 cm, a 32Fr (French) tube is often selected. For patients with a height between 152 - 165 cm, a 35Fr tube is often selected. For patients with a height between 165 - 177 cm, a 37Fr tube is often selected. For patients with a height of more than 177 cm, a 39Fr tube is often selected.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The anesthesiologists do not implement the blinding method for the patient grouping, while the physicians conducting the postoperative follow-up implement the blinding method for the grouping.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for thoracoscopic pulmonary resection using a left double-lumen tube under general anesthesia.
- •Patients aged 18-80 years
- •Chest CT scan in our hospital within one month before surgery
- •American Society of Anesthesiologists (ASA) physical status I to III
排除标准
- •Anticipated difficult airway
- •Patients with tracheal/left main bronchus anomalies
- •Height <152 cm
- •Refused to participate in the study
研究组 & 干预措施
The Regular Left Double-lumen Endobronchial Tube Group
干预措施: Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods (Device)
The Down-size Left Double-lumen Endobronchial Tube Group
干预措施: Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method (Device)
结局指标
主要结局
Intubation allocation time
时间窗: During induction of general anesthesia
The time duration required to complete Double-lumen tube intubation and positioning
次要结局
- Time of double-lumen tube insertion(During induction of general anesthesia)
- Time of successfully positioning of fiberoptic bronchoscope in supine position(During induction of general anesthesia)
- First-pass success rate of intubation(During induction of general anesthesia)
- The incidence of air leakage in double-lumen bronchial tubes(During induction of general anesthesia)
- Videolaryngoscope VIDIAC score(During induction of general anesthesia)
- Intubation resistance(During induction of general anesthesia)
- Intubation depth(During induction of general anesthesia)
- Adverse events during intubation(During induction of general anesthesia)
- Misplacement rate after position change (movement distance>1.0 cm)(During induction of general anesthesia)
- Campos atelectasis classification(5 minutes and 20 minutes after the distal port of the double-lumen tube is opened)
- Accumulated usage times of fiberoptic bronchoscope(During the operation)
- The incidence of misplacement during the operation(during the operation)
- Number of intraoperative double-lumen tube adjustments(During the operation)
- The incidence of hypoxemia intraoperatively(During the operation)
- Intraoperative single-lung ventilation time(through study completion，an average of 1-4 hours)
- Carina mucosa injury score(During the operation)
- Multiplanar Reconstruction（MPR) of lung CT measurement data(after operation，an average of 1-3 days)
- Bronchial window measurement data(after operation，an average of 1-3 days)
- PACU stay time(after operation，an average of 60-120 minutes)
- The incidence of sore throat(One hour, twenty-four hours, forty-eight hours after surgery)
- The incidence of postoperative cough(One hour, twenty-four hours, forty-eight hours ，thirty days after surgery)
- Postoperative pain score(twenty-four hours, forty-eight hours ，thirty days after surgery)
- Postoperative chest tube removal time(after operation through study completion，an average of 3-4 days)
- Length of hospital stay after surgery(after operation through study completion，an average of 3-7 days)
- Postoperative 30-day complications(within 30 days after surgery)
- The incidence of postoperative pulmonary complications(within 30 days after surgery)
- the postoperative recovery(on postoperative day 1)
- Intraoperative Partial Pressure of Arterial Oxygen (PaO₂)(During the operation)
- Intraoperative Partial Pressure of Arterial Carbon Dioxide (PaCO₂)(During the operation)
- Intraoperative Partial Pressure of Arterial Oxygen (PaO₂)(During the operation)
- Time of laryngoscope insertion(During induction of general anesthesia)
- Number of intubation attempts(During induction of general anesthesia)
- The incidence of Intubation difficulty(During induction of general anesthesia)
- Intubation resistance(During induction of general anesthesia)
- Intubation depth(During induction of general anesthesia)
- Accumulated usage times of fiberoptic bronchoscope(During the operation)
- The incidence of misplacement during the operation(during the operation)
- Number of intraoperative double-lumen tube adjustments(During the operation)
- The incidence of hypoxemia intraoperatively(During the operation)
- Intraoperative single-lung ventilation time(through study completion，an average of 1-4 hours)
- Carina mucosa injury score(During the operation)
- Time of double-lumen tube insertion(During induction of general anesthesia)
- First-pass success rate of intubation(During induction of general anesthesia)
- The incidence of air leakage in double-lumen bronchial tubes(During induction of general anesthesia)
- Videolaryngoscope VIDIAC score(During induction of general anesthesia)
- Adverse events during intubation(During induction of general anesthesia)
- Multiplanar Reconstruction（MPR) of lung CT measurement data(after operation，an average of 1-3 days)
- Bronchial window measurement data(after operation，an average of 1-3 days)
- PACU stay time(after operation，an average of 60-120 minutes)
- The incidence of sore throat(One hour, twenty-four hours, forty-eight hours after surgery)
- The incidence of postoperative cough(One hour, twenty-four hours, forty-eight hours ，thirty days after surgery)
- Postoperative pain score(twenty-four hours, forty-eight hours ，thirty days after surgery)
- Time of successfully positioning of fiberoptic bronchoscope in supine position(During induction of general anesthesia)
- Misplacement rate after position change (movement distance>1.0 cm)(During induction of general anesthesia)
- Campos atelectasis classification(5 minutes and 20 minutes after the distal port of the double-lumen tube is opened)
- Postoperative chest tube removal time(after operation through study completion，an average of 3-4 days)
- Length of hospital stay after surgery(after operation through study completion，an average of 3-7 days)
- Postoperative 30-day complications(within 30 days after surgery)
- The incidence of postoperative pulmonary complications(within 30 days after surgery)
- the postoperative recovery(on postoperative day 1)
- heart rate before and after intubation(Baseline. At 1，2,5 minutes after intubation.)
- mean arterial pressure before and after intubation(baseline.At 1，2,5 minutes after intubation.)
- Intraoperative Partial Pressure of Arterial Carbon Dioxide (PaCO₂)(During the operation)
研究者
Gu Bin
Clinical Professor
Zhejiang Cancer Hospital