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临床试验/CTRI/2024/06/068473
CTRI/2024/06/068473尚未招募4 期

Comparative effect of airway blocks, local anaesthetic nebulization and Spray as you go technique for awake flexible bronchoscope assisted nasotracheal intubation: A Randomized Interventional Study at SMS Medical College, Jaipur

SMS Medical College And Attached Hospitals1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2024年6月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
93
试验地点
1
主要终点
1. Mean time taken for intubation ( in seconds) from introduction of tip of flexible

研究概览

简要总结

Flexible bronchoscopy assisted nasotracheal intubation is the standard technique in patients undergoing head and neck cancer surgeries. Awake flexible bronchoscopy is usually recommended in difficult airway situations because an awake patient can sustain ventilation and oxygenation without assistance, pharyngeal muscle tone and phonation are preserved, can swallow its secretions thus keeping the pharynx clear and other alternatives to deal with the difficult airway can still be used. Thus it is essential to anesthetize the upper airway adequately and suppress the gag, swallow, and cough reflexes prior to awake flexible bronchoscope (FOB) guided intubation to ensure patient comfort. The various techniques for local anaesthesia of the airway include nebulisation using a nebuliser, spraying local anaesthetic directly over the mucosa through the working channel of the flexible bronchoscope which is also called ‘spray as you go’ technique or by giving nerve blocks.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing Head and Neck Cancer surgeries requiring awake nasotracheal intubation with flexible bronchoscope.
  • Patients willing to participate in the study
  • Adult patients aged between 30-80 Years of either gender
  • Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III.

排除标准

  • 1.Patient should not be a part of other study 2.Patients with the history of obstructive sleep apnea, nasal trauma, nasal surgery and bleeding diathesis 3.Patients with history of allergy to the study drugs.
  • 4.Non cooperative patients.
  • 5.Coagulopathies, any neuropathy.

结局指标

主要结局

1. Mean time taken for intubation ( in seconds) from introduction of tip of flexible

时间窗: During time of fibroscopy and intubation

bronchoscope in the nostril till the cuff of endotracheal tube crosses vocal cords

时间窗: During time of fibroscopy and intubation

2. Percentage of Intubation score

时间窗: During time of fibroscopy and intubation

3. Percentage of Five point Patient comfort score

时间窗: During time of fibroscopy and intubation

次要结局

  • 1. Mean of hemodynamic variables ( SBP, DBP, MAP, HR, SpO2)(2. Percentage of complications ( Bradycardia, Tachycardia, Hypertension, laryngospasm,)

研究者

发起方
SMS Medical College And Attached Hospitals
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sushil Bhati

SMS Medical College

研究点 (1)

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