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临床试验/CTRI/2021/01/030266
CTRI/2021/01/030266尚未招募不适用

Perioperative complications in children undergoing airway foreign body removal by rigid bronchoscopy under general anaesthesia – an observational study.

Post Graduate Institute of Medical Education And Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To determine the incidence of various perioperative complications in children undergoing airway foreign body removal by rigid bronchoscopy under general anaesthesia.

研究概览

简要总结

Foreign Body (FB) aspiration refers to the accidental entry of foreign body into the airway either through mouth or nose. It can occur at any age but is mostly seen in children less than 3 years of age. This occurs because young children tend to explore objects orally, along with their inability to chew the food adequately due to incomplete dentition, and due to incoordinated swallowing-breathing at this age.

The clinical features following FB aspiration depend on many factors including nature of the FB – whether organic or inorganic, size of the FB, and the duration of aspiration. The diagnosis of airway FB depends largely on history, clinical findings, and radiological imaging. Bronchoscopic removal of FB is recommended once the diagnosis is established. Both rigid and flexible fiberoptic bronchoscopes can be used for FB removal. Rigid bronchoscopes are preferred over flexible bronchoscopes because they provide a wide channel for insertion of instruments for the removal of FB. The rigid bronchoscopes also allow ventilation during the procedure through the side port.

Rigid bronchoscopy is performed under general anaesthesia. A deep plane of anaesthesia is required for the procedure. Even though bronchoscopy is safer now than it was earlier, it is associated with several complications, the reasons being the presence of airway and pulmonary pathology due to the FB, sharing of the airway by the surgeons and the anaesthetists, periods of apnoea during the procedure, among others. Minor complications include trauma to the teeth, oropharynx, or vocal cords, desaturation, hypotension, hypertension, bradycardia, tachycardia, need for postoperative oxygen supplementation, transient coughing/stridor/dyspnea after the procedure. Major complications include laryngeal edema, laryngospasm, bronchospasm, cardiac arrhythmias, pneumothorax, subcutaneous emphysema, tracheal perforation, need for postoperative mechanical ventilation or unplanned ICU admission, cardiorespiratory arrest and death.

The incidence of these adverse events is dependent on several patient, procedure and anaesthesia related factors. A few studies have evaluated the risk factors which are associated with these complications. However, most studies are retrospective in nature.

There are very few Indian studies which have studied the risk factors associated with complications during bronchoscopy. The aim of the present study is to determine the incidence of various perioperative complications in children undergoing airway foreign body removal by rigid bronchoscopy under general anaesthesia. We also propose to determine the risk factors for the development of perioperative complications.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • Children less than 13 years of age undergoing rigid bronchoscopy foreign body removal.

排除标准

  • 未提供

结局指标

主要结局

To determine the incidence of various perioperative complications in children undergoing airway foreign body removal by rigid bronchoscopy under general anaesthesia.

时间窗: Intraoperative and Postoperative period

次要结局

  • To determine the risk factors for the development of perioperative complications in children undergoing foreign body removal by rigid bronchoscopy under general anesthesia(Intraoperative and postoperative periods)

研究者

发起方
Post Graduate Institute of Medical Education And Research
申办方类型
Research institution and hospital

研究点 (1)

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