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临床试验/CTRI/2025/08/092282
CTRI/2025/08/092282尚未招募不适用

Preoxygenation obviates the need of bag and mask ventilation after induction of general anesthesia-A prospective, observational, case control, pragmatic trial

Dr Soumya Sankar Nath1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年9月1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
25
试验地点
1
主要终点
The primary outcomes that will be measured is the percentage of patients whose SpO2 drops below 95%.

研究概览

简要总结

Pre-oxygenation meaning patient made to breathe pure oxygen prior to administration of general anesthesia (GA) is an time-honoured practice among anesthesiologists It aids in denitrogenation of the lungs and allows longer apnea time. After induction of GA including muscle relaxant for a variable period till adequate effect of muscle relaxant is established the patients are ventilated by bag and mask with pure oxygen During bag and mask ventilation there is the the potential risks of gastric insufflation (predisposes patients to aspiration and gastric injuries during laparoscopic surgeries) and hyperventilation (raises the intrathoracic pressure leading to reduced cardiac output and hypotension)We hypothesise that with adequate preoxygenation, there is no need of bag and mask ventilation of patients after induction of GA till endotracheal intubation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Consenting adult patients (18-70 years), of both genders, of American Society of Anaesthesiologists functional class I or II, planned for elective surgery under GA with muscle relaxant, endotracheal intubation and controlled ventilation, AND in whom there exists need for intra-arterial cannulation.

排除标准

  • ASA functional class III and more, emergency surgeries, pregnancies, and lung related issues like chronic obstructive airway diseases, restrictive diseases, bronchial asthma, anticipated difficult airway, oropharyngeal or facial abnormalities making mask ventilation difficult and increased risk of aspiration.

结局指标

主要结局

The primary outcomes that will be measured is the percentage of patients whose SpO2 drops below 95%.

时间窗: At the end of period of apnea when the second sample of blood gas is collected

次要结局

  • 1. a. To compare the peripheral oxygen saturation (SpO2), partial pressure of carbon dioxide levels, and pH among patients who were ventilated with bag and mask and those who were not ventilated during the apnea period.(One year)
  • b. To measure the safe apnea period among patients who were not ventilated during the apnea period.(One year)

研究者

发起方
Dr Soumya Sankar Nath
申办方类型
Other [Principal Investigator]
责任方
Principal Investigator
主要研究者

Soumya Sankar Nath

Dr Ram Manohar Lohia Institute of Medical Sciences

研究点 (1)

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