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临床试验/CTRI/2024/06/069195
CTRI/2024/06/069195招募中不适用

Prospective Observational Study Of Perioperative Airway Management In Adult Patients With Central Airway Obstruction

Tata memorial Centre Mumbai1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
1. Preference of different types of airway management plan based on site and degree of obstruction

研究概览

简要总结

Airway obstruction is a potentially life threatening condition with a wide variety of aetiologies that can lead to a number of complications ranging from respiratory failure, arrhythmias, cardiac arrest and even death.

In general, airway obstruction is broadly classified into upper airway obstruction which refers to the obstruction of air flow in the portion of the airway that extends from the nose till the trachea and therefore includes the nasopharynx and larynx. Central airway obstruction which refers to the obstruction of airflow in the trachea and mainstem bronchi. Lower airway obstruction refers to the obstruction distal to the mainstem bronchi.

Causes of central airway obstruction are typically classified as malignant or nonmalignant or in accordance to the location ie intraluminal or extraluminal or according to the nature of the obstruction ie dynamic (eg;tracheobronchomalacia) or fixed.

Management of central airway obstruction is complex and challenging. Management is usually individualised rather than protocolised. There are no clear guidelines regarding anaesthesia techniques for airway management. General anaesthesia with inhalational or intravenous techniques, with or without muscle relaxants or awake techniques for airway control may be used based on the type and degree of airway obstruction, experience of the anaesthesiologist and availability of equipment.

This prospective observational study is aimed at understanding the airway management practices and outcomes in patients with central airway obstruction undergoing anaesthesia in our institute.

The main objectives of the study is to

1)Assessment of the location, extent and nature of the obstruction based on radioimaging/fibreoptic nasoendoscopy, PFT and other modalities.

2)Assessment of the airway equipment used to secure the airway based on the location, extent, nature of the obstruction and other patient factors.

3)Assessment of the factors considered while planning the airway strategy (eg;awake or under GA).

4)Assess the impact of the proposed airway management in patient outcome.

The total study duration is 2 years.The total sample size is 200 patients.

All adult  patients in Tata Memorial Hospital,Parel with central airway obstruction undergoing anaesthesia in emergency and elective setting will be included in the study after taking an written informed consent.

Data will be collected in the Case Record Form. Details regarding patient characteristics, surgical procedure and anaesthesia details will be collected prospectively from the patients’ electronic and physical records. Details regarding airway management plan and its success, failure and complications will be captured.

Demographic data will be summarized with descriptive statistics. Continuous data will be represented as mean (Standard deviation), or Median (IQR) and categorical data will be reported in counts (percentage) respectively. The Shapiro-Wilk’s test will be used to check normality of each variable. Categorical data will be compared using chi square test such like Pearson’s chi square test and fisher’s exact test. Comparison of continuous data will be done by using t test or Mann Whitney U test.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All adult patients with central airway obstruction undergoing anaesthesia in emergency and elective setting.

排除标准

  • Paediatric patients Supraglottic obstruction and obstruction distal to mainstem bronchi.

结局指标

主要结局

1. Preference of different types of airway management plan based on site and degree of obstruction

时间窗: After intubation or alternative airway control intraoperatively

次要结局

  • 2. Success rate of primary plan (plan A) of airway management.(3. Complications during airway management.)

研究者

发起方
Tata memorial Centre Mumbai
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Madhavi Shetmahajan

Tata memorial Centre, Mumbai

研究点 (1)

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