跳至主要内容
临床试验/NCT06101407
NCT06101407已完成不适用

Univent Tube for Thoracoscopic Thymectomy in Myasthenic Patients: an Observational Study

Nguyen Dang Thu0 个研究点目标入组 83 人开始时间: 2016年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
主要终点
Neuromuscular transmission at intubation time.

研究概览

简要总结

This observational study included consecutive MG patients who underwent thoracoscopic thymectomy with Univent tube intubation under general anesthesia without NMBAs and combined with airway topical anesthesia between January 2016 and December 2019. The investigators focus on intubation conditions, surgical conditions, intraoperative respiratory, and airway complications

详细描述

This prospective study was conducted on MG patients who underwent thoracoscopic thymectomy under general anesthesia without NMBAs using Univent tube at Vietnam Military Hospital 103 from January 2016 to December 2019. MG was definitively diagnosed based on clinical features, electromyography results, and/or circulating antibodies against acetylcholine receptors and classified according to the Osserman Classification. Preoperative evaluations included CT scans, pulmonary function tests, and routine exams. The operative risk and airway assessments were evaluated by expert anesthesiologists and excluded patients with preexisting hoarseness or sore throat. This study was approved by Hanoi Medical University's ethics committee (No.168-QĐ/ĐHYHN) and Military Hospital 103. All patients were anesthetized and intubated by one anesthesiologist assigned to the thoracic surgery unit.

Anesthesia procedure

In the operating theatre, the standard monitoring included electrocardiogram (ECG), invasive arterial blood pressure (IABP), peripheral oxygen saturation (SpO2), end-tidal capnography (EtCO2), ventilation peak and plateau pressures, continuous spirometry, and entropy (response entropy-RE and state entropy-SE; Datex Omeda S/5 Advance, GE, USA). Neuromuscular monitoring was recorded in the left forearm using TOF (train-of-four)-WatchsSX (Organons, Oss, the Netherlands).

Patients were pre-oxygenated with 100% oxygen for 5 minutes before induction with sufentanil at 0.5 µg.kg-1 and propofol at 2-3 mg.kg-1. When patients lost their eyelash reflex, lidocaine 10% was initially sprayed in the oral cavity, oropharynx, and upper part of the larynx. Subsequently, lidocaine 2% was administered using The MADgic Laryngo-Tracheal Mucosal Atomization Device (Teleflex, Wayne, Pennsylvania, USA) to cover the oral cavity, oropharynx, larynx, vocal cords, and as deep as possible into the trachea.

Once the SE value reached 50 or lower, a Univent tube (Fuji Systems, Tokyo, Japan) was intubated using conventional direct laryngoscopy. The tube size was standardized based on the patient's sex, with an 8.0-mm inner diameter (ID) used for men and a 7.0-mm ID used for women. Depending on the side of the chest for approaching the anterior mediastinum, the endobronchial blocker was carefully guided into either the right (for a right-sided approach) or left mainstem bronchus (for a left-sided approach) using flexible fiberoptic bronchoscopy. The tracheal and blocker cuffs were gently inflated, ensuring that the intracuff pressure stayed below 30 cmH2O, as measured by a noninvasive manometer. Following the secure positioning of patients in a 45° lateral decubitus orientation for surgery, with their heads firmly fixed, the correct placement of the blocker was reassessed through bronchoscopy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Myasthenia gravis patients
  • Undergoing thoracoscopic thymectomy
  • Undergoing general anesthesia

排除标准

  • Mallampati IV
  • Surgical complications

结局指标

主要结局

Neuromuscular transmission at intubation time.

时间窗: During surgery

Neuromuscular transmission was measured using TOF value (%) at intubation time.

Rate of lung collapse

时间窗: During surgery

During the surgical procedure, After opening the pleura and directly examining the quality of lung collapse as follows: 1. - spontaneous 2. - assisted with suction 3. - manual

Rate of intubation conditions

时间窗: During surgery

Intubation conditions are categorized as: * excellent * good * poor

Rate of reaction to tracheal tube insertion and cuff inflation

时间窗: During surgery

Reaction to tracheal tube insertion and cuff inflation are evaluated based on diaphragmatic movement/coughing and categorized as: * none * slight * vigorous/sustained

Rate of laryngoscopy difficulty

时间窗: During surgery

Laryngoscopy difficulties are categorized as: * easy * fair * difficult

Rate of vocal cord position

时间窗: During surgery

Vocal cord positions are categorized as: * abducted * intermediate/moving * closed

Rate of surgical conditions

时间窗: During surgery

The surgical conditions, as evaluated by surgeons and categorized as: 1. - excellent (complete collapse with perfect surgical exposure) 2. - fair (total collapse, but the lung still has residual air) 3. - poor (no collapse or partial collapse with interference in surgical exposure)

次要结局

  • Rate of bronchial injuries(After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.)
  • Rate of postoperative sore throat(After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.)
  • Rate of postoperative hoarseness(After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.)
  • Rate of vocal cord injuries(After anesthesia emergence and up to 3-day post-surgeries or until complete resolution.)

研究者

发起方
Nguyen Dang Thu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nguyen Dang Thu

Principal Investigator

Vietnam Military Medical University

相似试验