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临床试验/CTRI/2024/09/073311
CTRI/2024/09/073311尚未招募4 期

Comparison of a bundle of interventions with existing practices to reduce anesthesia induced atelectasis in elderly undergoing general anesthesia for non-cardiac surgeries – A double blind, randomized controlled trial.

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
130
试验地点
1
主要终点
To compare the incidence of anesthesia induced atelectasis in both groups after surgery using

研究概览

简要总结

The incidence of anesthesia induced atelectasis was found to be 90% in patients undergoing general anesthesia. And anesthesia induced atelectasis accounts for nearly 30% for the development of postoperative pulmonary complications which have a major impact on the mortality and morbidity of patients undergoing major surgery. There have been studies for techniques to reduce the incidence of anesthesia induced atelectasis in isolation. So, we hypothesise that these interventions when combined together (bundle) will be more effective than existing institutional practices in reducing anesthesia induced atelectasis.

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
65.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients posted to surgeries under general anesthesia with duration of surgeries more than or equal to 2 hours belonging to ASA I.
  • III including elective and emergency operations, as well as both laparoscopic and open surgical techniques.

排除标准

  • Patient refusal to give consent, patients with BMI more than or equal to 30 kg/m2, with pre-existing lung disease / chest trauma, patients posted for cardiothoracic/lung surgeries, patient not getting extubated within 24 hours of surgery in ICU, Pregnant woman, patients with progressive neuromuscular weakness, chronically bed-ridden, patients posted for redo surgeries.

结局指标

主要结局

To compare the incidence of anesthesia induced atelectasis in both groups after surgery using

时间窗: Before induction of anesthesia and after 1 hour of surgery and within 24 hours if patient shifted to ICU intubated

lung aeration score of score more than or equal to 2 by lung ultrasonography

时间窗: Before induction of anesthesia and after 1 hour of surgery and within 24 hours if patient shifted to ICU intubated

次要结局

  • To compare the incidence of anesthesia induced atelectasis in Laparoscopic & Open(surgeries)
  • To compare the incidence of postoperative pulmonary complications(Seven days postoperatively or till the day of discharge)
  • To compare the effect of predefined causes for anesthesia induced atelectasis such as(age, PEEP, position of surgery, etc.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Avinash R Naik

AIIMS Bhubaneswar

研究点 (1)

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