跳至主要内容
临床试验/CTRI/2016/07/007087
CTRI/2016/07/007087招募中不适用

Effect of supplemental oxygen by nasal cannula during apnea interval of intubation- a prospective randomized double blind trial.

All India Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
1. Prolongation of time for saturation to come from 100% to 92% during laryngoscopy

研究概览

简要总结

This study is a randomized, double blind, parallel grouptrial assessing the effectiveness of supplemental oxygen nasal insufflationduring apneic period of laryngoscopy in the supine sniffing position, as compared to no oxygen insufflation. Theprimary outcome measures will be assessing increase in desaturation safetyperiod when arterial saturation comes down to 92% after giving the muscle relaxant and also to assess effect onpartial pressure of oxygen in arterial blood after intubation of this passive nasal oxygen insufflation. The secondary outcome will be compare the recovery time foroxygen saturation to reach 100% from 92% after initiation of positive pressure ventilation with 100% oxygen.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • •The patients shall be ASA: Grade 1 with Body Mass Index of < 25 Kg/m2.

排除标准

  • •Any lung pathology or respiratory problem History of any heart disease or cerebrovascular disease Pregnant patients Anaemia (haemoglobin < 10gm/dl) Known difficult airway or modified mallampatti score >2 Smokers.
  • •Any contraindication for nasal prong use eg tumors, fractures, trauma.

结局指标

主要结局

1. Prolongation of time for saturation to come from 100% to 92% during laryngoscopy

时间窗: 1. Arterial oxygen samples shall be taken thrice. Once before oxygenation is initiated ie time 0, then at 3 minutes of start of study and also after intubation has been confirmed. | 2. After giving muscle relaxant ie. roughly 4 minutes after start of study, time taken for hemoglobin oxygen saturation to fall to 92% shall be noted. | 3. Time required for saturation to recover to 100% once it has fallen to below 92% shall also be noted.

2. Increase in arterial oxygen due to supplemental oxygen insufflation

时间窗: 1. Arterial oxygen samples shall be taken thrice. Once before oxygenation is initiated ie time 0, then at 3 minutes of start of study and also after intubation has been confirmed. | 2. After giving muscle relaxant ie. roughly 4 minutes after start of study, time taken for hemoglobin oxygen saturation to fall to 92% shall be noted. | 3. Time required for saturation to recover to 100% once it has fallen to below 92% shall also be noted.

次要结局

  • Recovery of saturation to 100% from 92%, after initiation of positive pressure ventilation with 100% oxygen(9 minutes)

研究者

发起方
All India Institute of Medical Sciences Patna
申办方类型
Government medical college

研究点 (1)

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