跳至主要内容
临床试验/CTRI/2023/08/056930
CTRI/2023/08/056930尚未招募2/3 期

A study to compare efficacy of four techniques of preoxygenation before induction of general anaesthesia in adults undergoing elective surgery

Armed Forces Medical College Pune1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月9日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Name of the drug:Inhaled Oxygen gas

研究概览

简要总结

  1. Preoxygenation aims to increase the oxygenstores physiologically to increase the time before desaturation startsoccurring. In the case of a rapid sequence of intubation when positive pressureis not preferred before intubation, denitrogenation is another way to look atpreoxygenation as the place of oxygen is being taken by high inspired oxygenconcentration.

  2. Optimal preoxygenation allows you to increasethe oxygen stores in the body. Preoxygenation is mostly achieved whenalmost all of the compartments like alveolar, tissue, and venous components arefilled with oxygen.

  3. Patients with less functional residualcapacity, hemoglobin concentration, reduced cardiac output, and increasedoxygen demand in the body tend to desaturate at a faster rate than normal patients.These types of patients generally need optimal preoxygenation.

  4. Difficult intubation may not always be predictable.In these cases, preoxygenation again becomes important and hence, performed inall patients for the same reason. Only very uncooperative patients of any agegroup can be considered as only an exclusion. Preventable but main reasons are failureto attain the FAo2 and inadequate time of preoxygenation

Aim of Study: To compare the efficacy of fourdifferent techniques of preoxygenation before induction of general anaesthesiafor elective surgery.

Objectives:

Primary Objective: To determine the time required foradequate preoxygenation i.e. End tidal oxygen of 90% using four differentmethods.

Secondary objective: To determine the various factorsaffecting adequate preoxygenation before induction of general anaesthesia forelective surgery in adult population.

Study Design**:** Prospectiverandomized trial

Patients will be randomly allocated in the four different groups:

GroupA: Eight vital capacity breaths at a pace comfortable to the patient.

GroupB: Tidal volume breathing using oxygen at 6 lpm by face mask.

GroupC: Tight fitting NIV mask (CPAP 5 cm of Water).

GroupD: Eight vital capacity breaths at a pace comfortable to the patient in Head up30degree posture.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • All patients undergoing elective surgeries within 18-70 yrs of age group.

排除标准

  • Pediatric age group less than 18 yrs 2) Patients requiring mechanical ventilator support or oxygen support of any kind before the induction of anaesthesia before elective surgery.
  • ASA 4 4) Term pregnancy for elective LSCS.

结局指标

主要结局

Name of the drug:Inhaled Oxygen gas

时间窗: The time taken to achieve end-tidal O2 of 90% while breathing 100% oxygen by various methods studied will be noted.

Duration: Less than 5 min

时间窗: The time taken to achieve end-tidal O2 of 90% while breathing 100% oxygen by various methods studied will be noted.

Achieving the EtO2 Of 90% is the primary outcome

时间窗: The time taken to achieve end-tidal O2 of 90% while breathing 100% oxygen by various methods studied will be noted.

To determine the time required for adequate preoxygenation i.e End tidal Oxygen of 90%.

时间窗: The time taken to achieve end-tidal O2 of 90% while breathing 100% oxygen by various methods studied will be noted.

次要结局

  • age(gender)

研究者

发起方
Armed Forces Medical College Pune
申办方类型
Government medical college

研究点 (1)

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