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临床试验/CTRI/2024/10/074738
CTRI/2024/10/074738尚未招募不适用

Comparison of High Flow Nasal Oxygenation and Face Mask Oxygenation for Prolongation of Safe Apnoea Time in Obese Patients Undergoing Elective Surgery under General Anaesthesia

ABVIMS and Dr Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年10月6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
62
试验地点
1
主要终点
1. Number of patients in each group in whom apnoea time is less than 6 minutes.

研究概览

简要总结

This is an interventional parallel group study design to compare high flow nasal oxygenation and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery under general anaesthesia ,since there is a paucity of studies  in the Indian population  for the same.The primary  objective is to compare high flow nasal oxygenation  and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery. The secondary objective are to compare  ventilation  and assess change in hemodynamic parameters and compare patient comfort between the two techniques. Patients will be allocated  in two groups ,with 31 patients in each group . Group A patients will receive preoxygenation with High Flow Nasal Oxygenation at 40L/minute for 1 minute  and 70L/minute  for 2 minutes ; Group B patients  will recieve preoxygenation with 100% oxygen through tightly held face mask at 10L/minute with CPAP of 5 cm of H2O. The primary outcome measures are number  of patients  in each group in whom apnoea time is less than 6 minutes and time taken  for spo2 to reach 94% .The secondary outcome measures are maximum etco2 reached after start of ventilation, arterial blood gas analysis at baseline,at the end of preoxygenation  and at the end of apnoea time, hemodynamic changes and patients comfort level.The data will be collected ,analysed and statistically evaluated  .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Body mass index (BMI) ≥30 kg/m2.

排除标准

  • Patients with risk factors for difficult airway (indication for flexible optic intubation, high risk of regurgitation or expected difficult mask ventilation).
  • Uncontrolled gastric reflux disease.
  • Inability to breathe through nose due to nasopharyngeal obstruction or compulsive mouth breather.
  • Pregnant patients.
  • Known case of any systemic disorder such as cardiac, respiratory, renal or hepatic.

结局指标

主要结局

1. Number of patients in each group in whom apnoea time is less than 6 minutes.

时间窗: Every 1 minute for 6 minutes

2. In these patients, time taken for SPO2 to reach 94% after induction of anaesthesia.

时间窗: Every 1 minute for 6 minutes

次要结局

  • 1) Maximum EtCO2 reached after start of ventilation.(2) Arterial blood gas analysis will be done at the following intervals. Baseline on room air , at the end of preoxygenation which is also start of apnoea time, and at the end of apnoea time.)

研究者

发起方
ABVIMS and Dr Ram Manohar Lohia Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Falak Faizan

ABVIMS and RML Hospital

研究点 (1)

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