跳至主要内容
临床试验/NCT07614529
NCT07614529尚未招募不适用

Evaluation of Efficacy and Safety of Hyperangulated and Standard Curvature Blade Video Laryngoscopy Versus Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation

Trakya University0 个研究点目标入组 180 人开始时间: 2026年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
180

研究概览

简要总结

This is a prospective, randomized, single-center, three-arm, open-label, low-risk medical device clinical study conducted at the Department of Anesthesiology and Reanimation, Trakya University Medical Faculty.

The study aims to compare the efficacy, safety, and clinical usability of three laryngoscopy methods for double-lumen endotracheal tube (DLT) intubation in patients undergoing elective thoracic surgery requiring one-lung ventilation: (i) C-MAC hyperangulated (D-blade) videolaryngoscopy, (ii) C-MAC Macintosh blade videolaryngoscopy, and (iii) direct Macintosh laryngoscopy.

The primary outcome is the total time to successful DLT placement (in seconds), defined as the interval from the end of mask ventilation to fiberoptic bronchoscopic confirmation of correct tube position. Secondary outcomes include glottic visualization quality (POGO score and Cormack-Lehane grade), intubation difficulty (Intubation Difficulty Scale), number of intubation attempts, need for auxiliary maneuvers, intubation-related complications, malposition rate, and postoperative airway symptoms (sore throat, dysphonia) assessed at 1, 6, and 24 hours postoperatively.

Eligible patients are adults (≥18 years), ASA class I-III, scheduled for elective thoracic surgery requiring one-lung ventilation. Patients with anticipated difficult airway, emergency surgery, pregnancy, or prior upper airway surgery are excluded. A total of 180 patients will be enrolled and randomized 1:1:1 into three groups (60 per group) using computer-generated block randomization.

详细描述

Background and Rationale:

Double-lumen endobronchial tubes (DLTs) are the primary airway device for one-lung ventilation (OLV) in intrathoracic surgery. Their use enables lung isolation, which is essential for surgical exposure in procedures such as lobectomy, pneumonectomy, esophagectomy, and thoracoscopic interventions. Despite their widespread use, DLT placement is technically more demanding than standard single-lumen endotracheal intubation due to the tube's larger outer diameter, greater length, increased rigidity, and the presence of a distal bronchial cuff. These structural characteristics make laryngoscopy and tube advancement through the glottis considerably more challenging and are associated with a higher incidence of oropharyngeal, laryngeal, and tracheobronchial trauma compared to standard intubation.

Airway injuries related to DLT placement span a wide spectrum, ranging from minor mucosal lacerations of the lips, tongue, and pharynx to temporary or permanent vocal cord damage. In rare but serious cases, tracheobronchial perforation has been reported, a potentially life-threatening complication. The increased structural difficulty of DLT intubation translates into a higher likelihood of multiple intubation attempts, each of which independently increases the risk of airway trauma, hemodynamic instability due to prolonged laryngoscopy, and desaturation. Minimizing the number of attempts and the total intubation time is therefore of direct clinical importance in this patient population.

Videolaryngoscopy (VL) has become increasingly integrated into routine and difficult airway management over the past two decades. By providing an indirect, magnified view of the glottis transmitted via a camera mounted at the tip of the blade, VL improves glottic visualization compared to direct laryngoscopy (DL), particularly in patients with anticipated or unanticipated difficult airways. Multiple meta-analyses and randomized controlled trials have demonstrated the superiority of VL over DL in terms of first-attempt success rate, Cormack-Lehane grade, and rate of esophageal intubation in both routine and difficult airway scenarios.

The Storz C-MAC system is one of the most widely studied videolaryngoscopes and is available in two blade configurations relevant to this study: the Macintosh-geometry blade (C-MAC M-blade), which allows both direct and indirect laryngoscopy and preserves familiar hand mechanics, and the hyperangulated D-blade (C-MAC D-blade), which provides a more acute viewing angle and is specifically designed for cases where standard geometry blades fail to achieve adequate glottic exposure. Both blades transmit a high-resolution image to an external monitor, and the C-MAC system has been shown to improve first-attempt success rates and glottic visualization in a range of clinical settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

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

入选标准

  • Age 18 years or older
  • Written informed consent obtained prior to surgery
  • ASA physical status class I, II, or III
  • Scheduled for elective thoracic surgery requiring one-lung ventilation and double-lumen endobronchial intubation

排除标准

  • Age under 18 years
  • Refusal or inability to provide informed consent
  • ASA physical status class IV or above
  • Emergency surgery
  • Anticipated difficult airway, defined by any of the following: Mallampati score 4, thyromental distance less than 6.5 cm, restricted mouth opening, or BMI greater than 30 kg/m²
  • History of upper airway surgery
  • Significant upper airway obstruction or stridor
  • Pregnancy

研究者

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

Havva Suheyla AKIN UZAN, MD

Assistant professor

Trakya University

相似试验