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临床试验/CTRI/2021/09/036699
CTRI/2021/09/036699已完成不适用

The effect of two different intraoperative inspired oxygen concentration on postoperative pulmonary atelectasis in Geriatric patients undergoing elective surgery under general anesthesia: a Randomized-Controlled Trial

All India Institute of Medical Sciences AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
To compare the incidence and severity of postoperative atelectasis determined by CT thorax.

研究概览

简要总结

All patients requiring general anaesthesia need oxygen administration. Supplementing patients with high inspired oxygen is considered to have harmful effects on lung physiology and increases the chances of postoperative pulmonary complications. But recent studies suggest that there is no clinically significant difference in postoperative lung atelectasis between low and high intraoperative inspired oxygen. However, high inspired oxygen is beneficial in reducing incidence of postoperative vomiting and surgical site infection. Most of the studies have been conducted in healthy individual to our best knowledge.

So,we planned to do a randomised study on the effect of two different intraoperative inspired oxygen concentrations on postoperative pulmonary atelectasis in geriatric patients undergoing elective surgeries.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Patients aged more than 60 years and scheduled for elective major surgery of duration more than 2 hours under general anaesthesia will be enrolled.

排除标准

  • •1.Patient undergoing cardio-thoracic surgery, thoracotomies 2.Patients with active upper or lower airway infection 3.Patients with abnormal preoperative chest Xâ€ray findings 4.Patients who are likely to require postoperative mechanical ventilation 5.Morbidly obese patients (BMI-35Kg/m2).

结局指标

主要结局

To compare the incidence and severity of postoperative atelectasis determined by CT thorax.

时间窗: To compare the incidence and severity of postoperative atelectasis during postoperative period upto 24hrs determined by CT thorax.

次要结局

  • 1.To compare postoperative gas exchange by PaO2/FIO2.(before preoxygenation and postoperatively at 1-hour, 6-hours and 12-hours)
  • 2.To compare incidence of postoperative nausea and vomiting.(24 hours postoperatively.)
  • 3.To compare incidence of surgical site infection.(Till 5 days postoperatively.)
  • 4.To compare requirement of postoperative respiratory support (oxygen supplementation/ mechanical ventilation).(Till day 3 postoperatively.)
  • 5.To compare incidence of postoperative pneumonia.(Till day 3 postoperatively.)

研究者

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

研究点 (1)

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