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临床试验/CTRI/2023/10/058602
CTRI/2023/10/058602尚未招募4 期

Clinical comparison of high flow nasal oxygen Vs low flow nasal co-oxygenation for reducing hypoxic events in patients undergoing fibreoptic bronchoscope guided orotracheal intubations:A randomised control trial

All India Institute Of Medical Science,Patna1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年12月10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
72
试验地点
1
主要终点
To estimate the percentage of patients in whom there is a fall of saturation (SPO2) more than 10 % from base line, during fibre optic bronchoscope guided orotracheal intubation.

研究概览

简要总结

A fibreoptic bronchoscope is used for both diagnostic and therapeutic purposes. In anesthesia, it is used to aid intubation especially during anticipated difficult airway situations. Hypoxemia during the process of fibreoptic bronchoscopic intubation is common. This can induce anxiety and hinder the performance of the procedure which in a difficult airway situation can be very cumbersome. Transient apnoea during fibreoptic bronchoscopy either produced due to the drugs or as a reflex due to irritation of the airway can also complicate the situation.

There are different ways of oxygen supplementation.  Traditionally this supplementation is by means of low-flow oxygen nasal cannula (LFNC) which can effectively provide only up to 4 to 6 liters per minute of supplemental oxygen. Often these flows are not enough and in more than 45% of patients desaturation has been noted. High flow nasal oxygenation is new system which is capable of delivering up to 100% humidified and heated oxygen at flow rates of upto 60 liters per minute, and a humidifier that saturates the gas mixture to a temperature of 31 to 37 C. A high-flow nasal cannula accomplishes a reduction of nasopharyngeal airway resistance, leading to improved ventilation and oxygenation through the application of a positive pressure environment. Hypoxemic events are reduced by other different proposed mechanisms (washout of dead space, intrinsic PEEP etc) which low flows can not do.

This prospective randomised study tries to assess whether high flow nasal oxygen reduce episodes of desaturation during fibrescope guided intubations when compared with standard low flow (6L/min) co-oxygenation in adult patients. It will also compare the lowest oxygen saturations  reached during intubation and the arterial partial pressures of oxygen and carbon dioxide at the confirmation of intubation. The total number of episodes of hypoxemic events (fall of SpO2 >10% from baseline) would also be noted and compared.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • All patients posted for elective surgery and needing oral fibreoptic bronchoscope guided intubation.

排除标准

  • Conditions precluding use of high flow nasal oxygen eg recent epistaxis, perforated nasal septum.
  • Patients in whom awake fibrescope guided intubation is indicated.
  • Mouth opening < 3 cm.
  • Pregnant women
  • Patients with history of trauma.
  • 6 when patients baseline saturation is <95%.

结局指标

主要结局

To estimate the percentage of patients in whom there is a fall of saturation (SPO2) more than 10 % from base line, during fibre optic bronchoscope guided orotracheal intubation.

时间窗: 10 minutes

次要结局

  • Lowest SpO2 during fibreoptic bronchoscope guided orotracheal intubation.
  • PaCO2 & PaO2 at the confirmation of intubation.(10 min)
  • PaO2 level at the start of fibreoptic bronchoscope guided orotracheal intubation.
  • No. of hypoxemic events ( fall of SpO2 10 % from baseline ) during fiberoptic bronchoscope guided orotracheal intubation.(10 minutes)

研究者

发起方
All India Institute Of Medical Science,Patna
申办方类型
Research institution and hospital

研究点 (1)

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