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临床试验/CTRI/2020/09/027981
CTRI/2020/09/027981尚未招募1/2 期

A Comparative study of Ambu Aura-i and Air-Q Supraglottic airway devices as conduit for blind tracheal intubation in patients with normal airway

SSG Hospital1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2020年9月29日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
SSG Hospital
入组人数
176
试验地点
1
主要终点
first attempt success rate of blind tracheal intubation through Ambu Aura-i and Air-Q supraglottic airway device

研究概览

简要总结

This study is to compare between the Ambu Aura-i and Air-Q supraglottic airway device (SAD), for use as conduit for blind tracheal intubation, in terms of ease and no. of attempts of SAD insertion, time taken for SAD insertion, ease and no. of attempts of intubation, time taken for intubation, first attempt and overall success rate of intubation, and effect on Hemodynamic parameters, when used in patients with ASA physical status I/II, with normal airway. It is a Prospective Ramdomised Clinical Study. We hypothesize that both Ambu Aura-i and Air-Q SADs are comparable in above mentioned terms.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 70 kgs ASA Physical status I/II Patients posted for elective surgeries under General Anaesthesia.

排除标准

  • Patients with predicted difficult airway ( mouth opening <2.5cm, Mallampati grade III & IV, limited neck extension, cervical spine problem, h/o previous difficult tracheal intubation) Patients with recent upper respiratory tract infection Patients with any oropharyngeal pathology Patient with any known pulmonary disease (like Asthma) and cardiovascular diseases (like hypertension).
  • Obese patients with BMI >30 kg/m2 Patient with any conditions that increase the risk of gastro oesophageal regurgitation.
  • H/O allergy to Latex or to any drugs used in protocol Patients not willing for participation.

结局指标

主要结局

first attempt success rate of blind tracheal intubation through Ambu Aura-i and Air-Q supraglottic airway device

时间窗: At the end of study

次要结局

  • ease of insertion of supraglottic airway device (SAD)(At the time of insertion of Supraglottic airway device)
  • no. of attempts of insertion of SAD(attempts at the time of SAD insertion)
  • time taken for insertion of SAD(in seconds, at the time of SAD insertion)
  • no.of attempts of tracheal intubation through SAD(attempts at the time of intubation)
  • time taken for tracheal intubation through SAD(in seconds, at the time of intubation)
  • ease of tracheal intubation through SAD(At the time of intubation through supraglottic airway device)
  • overall success rate of blind tracheal intubation through Ambu Aura-i and Air-Q(At the end of the study)

研究者

发起方
SSG Hospital
申办方类型
Government medical college

研究点 (1)

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