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临床试验/NCT06403696
NCT06403696已完成不适用

Ultrasonography-based Prediction of Post-operative Airway Complications in Pediatric Patients

Çanakkale Onsekiz Mart University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月2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
80
试验地点
1
主要终点
Association between Difference in Subglottic Airway Wall Thickness, and Postoperative Airway Complications

研究概览

简要总结

Laryngospasm and post-extubation stridor are major postoperative airway difficulties in pediatric patients using tracheal tubes. These conditions are frequently caused by epithelium edema and anesthesia-related problems. Because it could reveal tracheal and laryngeal issues, ultrasound is an essential method for establishing the proper endotracheal tube size and minimizing difficulties. This research focuses on the use of ultrasonography to predict and understand pediatric postoperative airway complications.

详细描述

In pediatric patients with tracheal tubes, laryngospasm, and post-extubation stridor are the two worst-case postoperative airway complications. Post-extubation stridor is caused by cricoid ring epithelial swelling, whereas laryngospasm is an uncommon but potentially fatal condition that occurs during the induction and recovery of anesthesia. When determining the proper endotracheal tube (ETT) size and minimizing postoperative problems, ultrasonography (USG) is important since it considers factors other than ETT size and irritation, like placement, surgical manipulation, and patient-specific circumstances. By displaying laryngeal and tracheal edema and the size and location of the ETT, ultrasound helps identify, at least in part, children who may experience respiratory issues. Thus, this research aims to illustrate how ultrasound could be utilized to predict the development of postoperative airway complications and to investigate the conditions that cause them in pediatric patients.

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
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 1-11 years
  • Anesthesia risk class: 1-2
  • Patients who have given written consent

排除标准

  • Patients aged under 1 or over 11 years
  • Patients undergoing emergency surgery
  • Patients with skin integrity issues such as open wounds, infections, or skin lesions in the area to be examined
  • Patients with laryngeal or tracheal deformities
  • Patients suspected of having a difficult airway
  • Patients who have previously undergone surgery on the upper airway, larynx, or trachea
  • Patients with a history of reactive airway disease (asthma, bronchial hyperreactivity)
  • Patients who have had an upper respiratory tract infection within the last two weeks
  • Patients with an anesthesia risk class of 3 or higher
  • Patients undergoing high-risk surgery

结局指标

主要结局

Association between Difference in Subglottic Airway Wall Thickness, and Postoperative Airway Complications

时间窗: Subglottic airway wall measurements are taken before intubation and extubation under general anesthesia, with complications assessed within the first hour postoperatively.

This measure assesses the association between an increase in subglottic airway wall thickness (measured in millimeters using ultrasonography) from pre-intubation to pre-extubation, and the incidence (%) of postoperative airway complications (categorical: presence or absence of cough, dysphonia, symptom of laryngospasm, and sign of upper airway obstruction). Measurement Tool: * Ultrasonography to measure subglottic airway wall thickness in millimeters. * The existence of post-operative airway complications is determined as follows: A post-operative airway complication is defined as cough, dysphonia, laryngospasm, or upper airway blockage within the first hour following surgery; if none of these findings are present, it is considered absent. Unit of Measure: * Millimeters for subglottic airway wall thickness. * Categorical outcome (yes/no) for airway complications

Association between Difference in Vocal Cord Thickness, and Postoperative Airway Complications

时间窗: Vocal cord measurements are taken before intubation and extubation under general anesthesia, with complications assessed within the first hour postoperatively.

This measure assesses the association between an increase in vocal cord thickness (measured in millimeters using ultrasonography) from pre-intubation to pre-extubation, and the incidence (%) of postoperative airway complications (categorical: presence or absence of cough, dysphonia, symptom of laryngospasm, and sign of upper airway obstruction). Measurement Tool: * Ultrasonography to measure vocal cord thickness in millimeters. * The existence of post-operative airway complications is determined as follows: A post-operative airway complication is defined as cough, dysphonia, laryngospasm, or upper airway blockage within the first hour following surgery; if none of these findings are present, it is considered absent. Unit of Measure: * Millimeters for vocal cord thickness. * Categorical outcome (yes/no) for airway complications

次要结局

  • Association Between Changes in Endotracheal Tube Position After Intubation and Before Extubation, and Postoperative Airway Complications(Measurements of endotracheal tube position are taken after intubation and before extubation under general anesthesia, with complications assessed within the first hour postoperatively)
  • Association Between Type of Surgery and Postoperative Airway Complications in Pediatric Patients(The type of surgery will be recorded at the preoperative examination, with airway complications assessed within the first hour postoperatively.)
  • Association Between Endotracheal Tube Position Before Extubation and Postoperative Airway Complications(Endotracheal tube position is recorded before extubation intraoperatively under general anesthesia, with complications assessed within the first hour postoperatively)
  • Association Between the Difference in Outer Diameter of the Endotracheal Tube and the Narrowest Airway Diameter, and Postoperative Airway Complications(Airway and tube diameter measurements are taken intraoperatively before intubation under general anesthesia, with complications assessed within the first hour postoperatively.)

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mihrican SAYAN

Specialist Doctor

Çanakkale Onsekiz Mart University

研究点 (1)

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