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临床试验/CTRI/2024/09/073704
CTRI/2024/09/073704尚未招募不适用

Comparison of PRAm and NARCO-SS risk assessment scores in assessing perioperative outcomes in paediatric patients

Meshach R1 个研究点 分布在 1 个国家目标入组 377 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
377
试验地点
1
主要终点
Compare the accuracy of PRAm and NARCO-SS scores in predicting perioperative

研究概览

简要总结

This is a prospective observational cohort study comparing the Pediatric Risk Assessment score (PRAm) and the Neurological, Airway, Respiratory, Cardiovascular, Other and Surgical severity (NARCO-SS) score. The primary objective is to compare the accuracy of PRAm and NARCO-SS scores in predicting perioperative outcomes among paediatric patients. The participants will be assessed prior to the surgery and scores will be assigned from the both scoring systems. The participants will then be then be followed up for 30 days after the surgery. The perioperative outcomes that will be recorded are predefined.

The secondary objective is to determine the inter-observer reliability of PRAm and NARCO-SS scores. A subset of the participants will be assessed prior to surgery by multiple observers and they will assign scores from both PRAm and NARCO-SS. This subset will be used to determine the secondary objective.

References

  1. PRAm Nasr VG, DiNardo JA, Faraoni D. Development of a Pediatric Risk Assessment Score to Predict Perioperative Mortality in Children Undergoing Noncardiac Surgery. Anesth Analg 2017; 124: 1514–1519.
  2. NARCO-SS Malviya S, Voepel-Lewis T, Chiravuri SD, et al. Does an objective system-based approach improve assessment of perioperative risk in children? A preliminary evaluation of the ‘NARCO’. Br J Anaesth 2011; 106: 352–358.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective or emergency non-cardiac surgery Patients less than 18 years of age of either gender.

排除标准

  • Patients involved in other studies.

结局指标

主要结局

Compare the accuracy of PRAm and NARCO-SS scores in predicting perioperative

时间窗: Intraoperative, immediate postoperative period while in | postanaesthesia care unit, each postoperative day until discharge and weekly telephonic follow-up | until 30th postoperative day.

outcomes among paediatric patients

时间窗: Intraoperative, immediate postoperative period while in | postanaesthesia care unit, each postoperative day until discharge and weekly telephonic follow-up | until 30th postoperative day.

次要结局

  • Inter-observer reliability of PRAm and NARCO-SS(During preoperative assessment of the patient)

研究者

发起方
Meshach R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Meshach R

Kasturba Medical College, Manipal

研究点 (1)

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