Comparison of intraoperative hypotension with and without hypotension prediction index tool in patients undergoing brain tumor surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- NIMHANS
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Duration of intraoperative hypotension in both the HPI group and the conventional group
研究概览
简要总结
Intraoperative hypotension (IOH) is a common and frequent side effect of anesthesia. Treatment of hypotension is currently reactive, which means that it starts after a hypotensive effect occurs. The type of treatment will depend on various hemodynamic variables that can be provided by basic or advanced monitoring techniques. However, even if these techniques can give detailed knowledge on the actual hemodynamic status of the patient, they cannot predict future hypotensive events. Therefore, hypotension will occur, and given that even brief episodes of intraoperative hypotension can be deleterious for the patient, the need for a prediction model becomes apparent.Values below a threshold of MAP below 60-70 mmHg are associated with myocardial injury, acute kidney injury, and death. The Hypotension Prediction Index algorithm on the EV 1000 system was developed by Hatib et al, with the help of machine learning. It uses 23 arterial waveform features to predict hypotension defined by MAP less than 65mm Hg for at least 1minute. The index values ranges from 0 to 100, with higher numbers reflecting a higher likelihood of subsequent hypotension. The index reportedly has 92% sensitivity and specificity for predicting hypotension 5minute in advance while sensitivity was 89% and specificity was 90% for 10min in advance and was 88% and 87% for 15min in advance. Therefore, with the use of HPI algorithm, hypotension can be theoretically predicted and subsequently prevented with adequate treatment. We aim to evaluate the role of Hypotension Prediction Index integrated with a hemodynamic management protocol on intraoperative hypotension during brain tumor surgery and peri-operative complications.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 18 and 65 years of either gender.
- •American Society of Anesthesiologists physical status (ASA-PS) I and II patients.
- •Undergoing elective surgery for excision of brain tumors with or without intraoperative neuromonitoring.
- •With brain tumors of size more than 4 cms.
- •Anticipated intraoperative bleeding of more than 500mL.
排除标准
- •Significant hypotension before surgey.
- •With known left or right cardiac failure.
- •With significant hypertension.
- •Arrhythmias (Atrial fibrillation), cardiac shunts, severe aortic stenosis.
- •Emergency surgery.
- •Surgery done in sitting position.
- •Pregnant women.
- •Refuse to give consent.
结局指标
主要结局
Duration of intraoperative hypotension in both the HPI group and the conventional group
时间窗: Baseline followed by every minute till the end of the case.
次要结局
- Time Weighted Average of intraoperative hypotension defined as the depth of hypotension with a fall in mean arterial pressure to less than 65mm Hg multiplied by the time spend with mean arterial pressure of less than 65mm Hg divided by the total duration of surgery(Baseline followed by every minute till the end of the case.)
- Incidence of intraoperative hypotension, defined as the number of hypotensive events. A hypotensive event is defined as reduction of mean arterial pressure to less than 65 mm Hg for at least 1min. The hypotensive event will end when the MAP value is normalised.(Baseline followed by every minute till the end of the case.)
- Severity of hypotension by calculating the time weighted average of intraoperative hypotension below 60mm Hg of MAP & below 55mm Hg of MAP between the two groups(Baseline followed by every minute till the end of the case.)
- Compare the amount of intraoperative crystalloid & collloids, erythrocyte transfusions, cumulative dose of the vasoactive medications, anesthetic & analgesics, depth of anaesthesia values, blood loss & urine output between the two groups(Baseline followed by every minute till the end of the case.)
- Compare the outcome measures- intraoperative vasopressor use, intraoperative myocardial ischemia ( ST segment values more than or less than 2mm), acute kidney injury ( changes in serum creatinine by more than 0.3mg% as per AKIN criteria), emergence ( Riker sedation agitation scale) & postoperative delirium ( confusion assessment method), new onset motor deficits ( perioperative stroke), length of ICU stay & duration of hospital stay.(Baseline followed by every minute till the end of the case.)
- To calculate the cost effectiveness/financial burden with the use of HPI index(Baseline followed by every minute till the end of the case.)
研究者
Dr Thomas Francis
National Institute of Mental Health and Neuro Sciences (NIMHANS)