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临床试验/NCT03069755
NCT03069755已完成不适用

What is the Perioperative Mortality Rate and What is the Association Between Type of Acute Surgical Intervention and Perioperative Mortality Among Adult Trauma Patients in an Urban Indian Setting?

Karolinska Institutet0 个研究点目标入组 16,047 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16,047
主要终点
Patient death

研究概览

简要总结

This study aims to estimate the perioperative mortality rate in adult trauma patients undergoing acute surgery as well as the association between type of acute surgery and perioperative mortality in university hospitals in urban India.

详细描述

Introduction

Trauma can be defined as damage inflicted on the body as the result of an external force, and the body's associated response. It is one of the leading causes of death world-wide, causing almost five million deaths yearly, making up for close to nine per cent of global deaths. Of these, road traffic injury alone causes 1.3 million, making it the ninth leading cause of death, with a predicted rise to seventh leading cause by 2030. Overall, however, the world has experienced an increase in life-expectancy over the past 30 years, as well as a decrease in infant and maternal mortality. With evidence suggesting that surgical care results in at least one million deaths per year, twice the number of maternal deaths, it has been established that new health metrics are needed for assessing health system performance.

The WHO Safe Surgery Saves Lives initiative proposes two metrics: day-of-surgery mortality, and 30-day postoperative in-hospital mortality. The subsequently introduced perioperative mortality rate (POMR) comprises these two. To date, no standard timespan for day-of-surgery measurement prevails - the same day as surgery has been suggested for convenience, while some institutions measure at 24, and others at 48 hours after surgery. The outcomes required to calculate POMR (death and number of surgeries) are easily defined. Additionally, there is an option to end follow-up at discharge, which makes the metric suitable for use in low-resource settings, where 30-day follow-up is rare. These are qualities that make POMR the choice of index for tracking the quality and safety of surgery in the world.

Analyses of databanks of surgical patients establish some factors that are more intimately linked to perioperative mortality (POM) than others. In trauma, especially, thorough risk adjustment is highly stressed to enable comparisons at hospital and patient level. However, the data yielding adjustment models largely stems from high-income countries, which is relevant considering that not all risk factors associated with POM in a high-resource setting are applicable in a low-resource setting. This owes to the scarcity of data on surgical programs in low-resource settings, not least in India. As the country faces increasing motorisation, and with it an increase in trauma patients for which factors associated with POM is poorly understood, bridging this knowledge gap is important.

Therefore, this study will be estimating the POMR and assessing the association between type of acute surgical intervention and POM among adult trauma patients in an urban Indian setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting alive to participating hospitals with history of trauma
  • ≥ 15 years
  • That the patient underwent surgical intervention within 24 hours of arrival

排除标准

  • Isolated limb injury

结局指标

主要结局

Patient death

时间窗: Within 30 days of arrival

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Gerdin

Researcher

Karolinska Institutet

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