CTRI/2024/06/068541尚未招募1 期
To compare hypotension predictive index and standard cardiac output monitoring in preventing hypotension in major abdominal surgeries
Self1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- determination of time weighted average(TWA) spent by the study group and control group in the trial
研究概览
简要总结
To compare Hypotension predictive index and standard cardiac output monitering in preventing hypotension in major abdominal surgeries.
To measure the time weighted average(TWA) spent in hypotension by the study and control group
To determine the incidence of intra operative hypotension.
To determine postoperative mortality in form of myocardial ischemia ,Acute kidney injury and prolonged ICU stay in relation to intraoperative hypotensive episode and its duration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age of subject 18 years and above 2) Scheduled for elective major abdominal surgery.
- •ASA grade II – IV 4) Need for continuous invasive blood pressure monitoring.
排除标准
- •Patients with significant hypotension as measured before surgery.
- •patients with known left or right cardiac failure, known arrythmias (e.g., atrial fibrillation), cardiac shunts, severe aortic stenosis or the need for dialysis will be excluded.
- •If surgery included clamping of the aorta or Pringle’s manoeuvre, the patient is not eligible for the trial.
- •Finally, emergency procedures will also be excluded from the trial.
结局指标
主要结局
determination of time weighted average(TWA) spent by the study group and control group in the trial
时间窗: Time weighted average will be calculated soon after the end of Anaesthesia for the specific surgery.
次要结局
- 1) Determination of the incidence of intraoperative hypotension, i.e. the number of hypotensive events, total time (in minutes) spent with hypotension & the percentage of time spent in hypotension during surgery.(2) Determining the effect of hypotensive episodes & its duration & its effect on postoperative mortality (28 days) in form of myocardial ischemia, & acute kidney injury (AKI) as well as prolonged stay in ICU)
研究者
Dr Premlal Sreekumar
Atal Bihari Vajpayee Medical university
研究点 (1)
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