跳至主要内容
临床试验/CTRI/2022/09/045817
CTRI/2022/09/045817尚未招募不适用

Utility of preoperative risk stratification using SKALE and Charlson co-morbidity scores to predict postoperative outcome in patients with intracranial tumours

Lokmanya Tilak Municipal Medical College1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
1
主要终点
1. To note feasibility of application of preoperative risk stratification scores- SKALE (sex, Karnofsky performance status (KPS), ASA physical status (ASA), location of tumour, edema), and Charlson co-morbidity index in patients with intracranial tumours.

研究概览

简要总结

After IEC-HR permission, all patients admitted inneurosurgical wards for neurosurgical procedure, satisfying all inclusion andexclusion criteria will be considered for inclusion into the study. All patients or their near relations willbe explained about the study and a written valid informed consent for theirwillingness to participate in the study will be taken. All demographic data ofthe patients will be noted from the patient’s history and case sheets. Later, adetailed preoperative assessment will be done on the patient and followingscores will be applied.

·      American society ofanaesthesiologists physical status( ASA-PS)

·      Glasgow coma scale (GCS)

·      Karnofsky performancescore (KPS)

·      SKALE- Sex, Karnofskyperformance score, American society of anaesthesiologist class, location oftumour and peritumoural edema grading system

·       CharlsonComorbidity Index

 Eachindividual feature of a particular scoring system is understood and thus markedwhichever describes the patient’s condition the best. Total score will becalculated for each scoring system.

Followingintraoperative variables will be noted.

·       Duration of surgery

·       Position of surgery

·       Intraoperative blood loss

·       Intraoperative adverse events if any.

o  Hypotension> 25% baseline

o  Arrhythmias

o  Hypoxia(spO2 <90%)

o  Airembolism

o  Anyother event affecting outcome

Need forventilator support with duration will be noted. Post surgery, the patient willbe reassessed on post operative day 1(POD1). All patients will be followed uptill discharge for noting their postoperative course in ward, any complicationsthat may develop and if any resurgery is needed. Karnofsky performance scorewill be assessed again prior to discharge and will be compared with thepreoperative status.

Differentscoring systems will be evaluated for their preoperative scores and theirpredictability of post operative outcome.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients posted for elective surgeries for intracranial tumour excision.

排除标准

  • patients/next of kin not willing to give consent for study patients planned for stereotactic biopsy patients planned for transnasal excision without craniotomy.

结局指标

主要结局

1. To note feasibility of application of preoperative risk stratification scores- SKALE (sex, Karnofsky performance status (KPS), ASA physical status (ASA), location of tumour, edema), and Charlson co-morbidity index in patients with intracranial tumours.

时间窗: before surgery, post operative day one of surgery and at discharge

2. To correlate each of these scores with postoperative complications and adverse outcome in patients with intracranial tumours.

时间窗: before surgery, post operative day one of surgery and at discharge

次要结局

  • To correlate ASA, GCS and KPS score individually with postoperative outcome in patients with intracranial tumours.

研究者

申办方类型
Research institution and hospital

研究点 (1)

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