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临床试验/NCT03368599
NCT03368599已完成不适用

The Effect of Endobronchial Intubation of Double-lumen Tube on Post-operative Sore Throat, Hoarseness and Airway Injuries: A Comparison Between Conventional and Fiberoptic Bronchoscope-guided Intubation

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2018年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
2
主要终点
Post-operative sore throat (24 h)

研究概览

简要总结

Double lumen tube (DLT) needs to be intubated to isolate ventilations of left and right lungs for thoracic surgery. Post-operative sore throat and hoarseness are more frequent with DLT intubation than with single one. Which is may because DLT is relatively thicker, harder, sideway curved and therefore more likely to damage the vocal cord or trachea during intubation, and advanced deeper to the carina and main bronchus level. In the conventional method of intubation, DLT is rotated 90 degrees and advanced blindly to the main bronchus level after DLT is intubated through vocal cord using the direct laryngoscopy. After the blind advancement, the sufficient tube position needs to be gained and confirmed with the fiberoptic bronchoscope. In the bronchoscope guide method, after DLT is intubated through vocal cord using the direct laryngoscopy, the pathway into the targeted main bronchus is secured using the fiberoptic bronchoscope which is passed through a bronchial lumen of DLT. And then DLT can be advanced through the guide of the bronchoscope. In this study, we intend to compare post-operative sore throat, hoarseness and airway injury between the two methods. We hypothesize that the bronchoscope guide method can reduce the post-operative complications and airway injury because surrounding tissues of the airway can be less irritated by DLT intubation in the guide method than in a conventional.

For a constant guide effect, we use fiberoptic bronchoscopes with same outer diameter (4.1 mm) which can pass through a bronchial lumen of 37 and 39 Fr Lt. DLT and cannot pass through 35 Fr or smaller Lt. DLTs.

<Lt. DLT size selection>

  • male: ≥160 cm, 39 French; < 160 cm, 37 French
  • female: ≥160 cm, 37 French; < 160 cm, contraindication

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)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiologists) class I - III
  • Elective thoracic surgery
  • Left-sided DLT intubation for one-lung ventilation

排除标准

  • Female, height < 160 cm
  • Pre-existing sore throat, hoarseness or airway injury
  • Duration of surgery > 6 h
  • Upper respiratory tract infection
  • Cervical spine diseases
  • Presence of tracheostomy
  • Pharyngeal neoplasm or abscess which can induce mechanical airway obstruction
  • Mallampati score 4
  • Obesity (BMI ≥ 35 kg/m2)
  • Obstructive sleep apnea (OSA)
  • Craniofacial anomaly
  • Cormack grade 3b or 4
  • History or high risk of difficult intubation / difficult mask ventilation
  • Patients whom the direct laryngoscopy cannot be used for, because of weak teeth or small mouth opening
  • Patients who refuse to participate in the study or from whom receive informed consent cannot be received.

研究组 & 干预措施

Bronchoscope guide group

Experimental

DLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement).

干预措施: Bronchoscope guided advancement (Procedure)

Conventional group

Active Comparator

DLT is advanced blindly to the main bronchus level (Conventional advancement).

干预措施: Conventional advancement (Procedure)

结局指标

主要结局

Post-operative sore throat (24 h)

时间窗: 24 hour after tracheal extubation

The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most

次要结局

  • Heart rate(Intraoperative)
  • Resistance against DLT passage through vocal cord(Intraoperative)
  • Intubation time(Intraoperative)
  • Airway injury (Lt. main bronhcus, carina, trachea)(Intraoperative)
  • The number of attempts for intubation(Intraoperative)
  • IV PCA(At 24 hours after the extubation)
  • Post-operative sore throat (1 h)(24 hours after tracheal extubation)
  • Resistance against DLT advancement(Intraoperative)
  • The number of right misplacement of Lt. DLT(Intraoperative)
  • Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning(Intraoperative)
  • Mean arterial pressure(Intraoperative)
  • Airway injury (vocal cord)(Intraoperative)
  • Dysphagia(24 hours after tracheal extubation)
  • Post-operative hoarseness (1 h)(1 hour after tracheal extubation)
  • Post-operative hoarseness (24 h)(24 hour after tracheal extubation)
  • Oral dryness(24 hours after tracheal extubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Woo Park

Assistant Professor

Seoul National University Bundang Hospital

研究点 (2)

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