跳至主要内容
临床试验/NCT03711461
NCT03711461Unknown不适用

Comparisons of the Risks of Gastric Distension and Delayed Recovery of Cough Reflex and Oral Intake on Intubated and Non-intubated VATS Patients

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年11月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
2
主要终点
impedance changes

研究概览

简要总结

the investigator aimed to observe the changes and difference of pharyngeal function parameters between the patients receiving the intubated or nonintubated thoracoscopy by esophageal manometry, impedance, and ultrasonography

详细描述

Background: Anesthetic agents alter pharyngeal function with risk of impaired airway protection and aspiration. The pharyngeal function change including the swallowing and gastric regurgitation between intubated and nonintubated thoracoscopy still remains unclear.

The esophageal manometry has pressure sensor to measure the upper esophageal sphincter (UES) pressure. The manometry and impedance could detect the esophageal swallowing function during the perioperative period. The ultrasonography was used to measure the oropharyngeal swallowing function.

Objectives:the investigator aimed to observe the changes and difference of pharyngeal function parameters between the patients receiving the intubated or nonintubated thoracoscopy by esophageal manometry, impedance, and ultrasonography.

Patients and methods: Consecutive patients who will fulfill the criteria of nonintubated patients under general anesthesia and age from 20 to 80 years old will be enrolled. All subjects would receive the swallowing function by ultrasonography before the surgeries. The cough test and gastric volume were also measured. The patient was randomized by the intubated or nonintubated thoracoscopy. After induction, the endotracheal tube (ETT) will be inserted to establish airway. The non-intubated group will be use the oxygen mask and the nasal airway to maintain the airway patent. After the patients were sedated, investigators would use the video-assisted laryngoscope to let the manometry and impedance transnasal into the esophagus.These esophageal function was measured during the whole perioperative periods, especially the recovery from anesthesia in the postoperative anesthesia unit (PACU). The patients will be followed for the swallowing function by ultrasonography and cough test in the PACU, too. The oxidative test would be performed by blood test on the time, which were after anesthesia, one-lung ventilation 15 to 30 minutes, and two-lung ventilation 15 to 20 minutes, respectively.

Expected result: investigators will observe the changes between the patients receiving intubated or nonintubated thoracoscopies of the changes between the preoperative and postoperative changes in the swallowing function, cough and gastric regurgitation. The oxidative test will also be tested accompanied by the anesthetic monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

the swallowing function assessor is blind

入排标准

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

入选标准

  • Patients who fulfill the criteria of nonintubated thoracoscopy under general anesthesia, including tumours smaller than 6 cm, peripheral lesions, no evidence of severe adhesion; and no evidence of chest wall, diaphragm, or main bronchus involvement. Patients who had potential or confirmed airway complications such as bronchial tumor or hemothorax, morbid obesity (BMI greater than 35 kg·m-2), coagulopathy, anatomical deformity or an American Society of Anesthesiology (ASA) classification greater than 3 were excluded
  • Aged from 20-80 years old

排除标准

  • Major systemic disease, such as congestive heart failure, liver cirrhosis, and end stage renal disease.
  • Patients who have the risk of difficult ventilation or intubation.
  • pregnant women
  • coagulopathy

结局指标

主要结局

impedance changes

时间窗: average 4 hours

using esophageal manometry to evaluate the swallowing

次要结局

  • esophageal pressure changes(average 4 hours)
  • hyoid bone distance(average 4 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验