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临床试验/NCT02036021
NCT02036021已完成不适用

Comparison of Cost of Hospitalization in Children After General Anesthesia With and Without Perioperative Respiratory Event at a Tertiary Care Hospital in Southern Thailand

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 1,004 人开始时间: 2012年11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
1,004
试验地点
1
主要终点
cost of hospitalization

研究概览

简要总结

Mortality related with cardiac arrest in anesthetized children has diminished over several decades from 2.9 per 10000 anesthesias in 1961 to 0.21 per 10000 anesthesias in 2007.(1) Even though the mortality rate related to pediatric anesthesia is much lower than before, respiratory complications related with peri-operative cardiac arrest are as high as 27% according to the Pediatric Peri-operative Cardiac Arrest (POCA) Registry.(2).Therefore, peri-operative respiratory event (PRE) in pediatric anesthesia such as laryngospasm, stridor, bronchospasm, desaturation and reintubation are crucial.

Stridor and reintubation occur after the children are extubated, mostly in the PACU period. Laryngospasm, stridor, bronchospasm and wheezing can lead to desaturation and the need for reintubation. Those PRE, especially peri-operative desaturation, can prolong PACU stay especially if PRE develops in the PACU.(8,9) PRE occurring during the intraoperative period can also prolong PACU stay if children are observed at PACU and not transferred directly to the intensive care unit (ICU). Some children require oxygen therapy in the PACU and continue at the ward. Some need endotracheal tube intubation with spontaneous breathing or are placed on mechanical ventilator. Thai AIMS (10) reported that desaturation at PACU was associated with re-intubation, prolonged mechanical ventilation and unplanned ICU admission. Oxygen supplement need, prolonged mechanical ventilation or unplanned ICU admission can produce extra days of hospitalization or increase the cost of hospitalization from extra-cost payment eg; oxygen therapy, mechanical ventilator, cost of ICU stayed.

Furthermore, the short-term sequelae regarding cost of hospitalization of children who develop PRE has never been evaluated or compared with the cost in children who do not develop PRE. Higher cost of hospitalization after occurrence of PRE in anesthetized children will have an impact to the hospital policy maker. Minimizing PRE can save on the cost of hospital care to the public hospital or other health sectors.

Therefore, we would like to compare days of hospitalization and cost differences of hospitalization between children who develop PRE and children who do not develop PRE at a tertiary care hospital in southern Thailand

详细描述

  1. Study design A prospective observational study
  2. Study setting Children aged < 15 years who received general anesthesia in Songklanagarind Hospital between November 2012 and December 2013
  3. Study samples Inclusion criteria Children aged < 15 years who received general anesthesia and developed PRE or who had no PRE in Songklanagarind Hospital between November 2012 and December 2013.

Exclusion criteria

  1. ASA classification 4 or 5

  2. Preoperative SpO2 < 95% at room air

  3. Required preoperative endotracheal tube intubation (ETT) or mechanical ventilation

  4. Had congenital cyanotic heart disease

  5. Study size Sample size calculation The sample size calculation is based on a comparison between groups of the outcomes of days and cost of hospitalization between PRE and non-PRE group 5. Sampling technique Purposive identification of children aged < 15 years old who receive general anesthesia and develop Peri-operative respiratory event (PRE) between November 2012 and December 2013.was selected for PRE or exposed group. Peri-operative respiratory event (PRE) is defined as any respiratory event eg; laryngospasm, stridor, wheezing, bronchospasm, reintubation, with or without desaturation, which occurs during the intraoperative or PACU period. For non-PRE or non-exposed group, the matching with exposed group on the same demographic data will be performed as below.

  • Matching on the same year of anesthesia
  • Matching on the same type of surgery
  • Matching on the same type of anesthesia After matching the same type of surgery and anesthesia with exposed group, non-exposed group will be randomly selected by simple random sampling technique if there are more than 4 suitable non-exposed subjects available. The ratio of exposed group and non-exposed group will be 1 to 4.

研究设计

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

入排标准

年龄范围
1 Day 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged < 15 years who received general anesthesia and developed PRE or who had no PRE in Songklanagarind Hospital between November 2012 and December 2013

排除标准

  • ASA classification 4 or 5
  • Preoperative SpO2 < 95% at room air
  • Required preoperative endotracheal tube intubation (ETT) or mechanical ventilation
  • Had congenital cyanotic heart disease

结局指标

主要结局

cost of hospitalization

时间窗: 15 months

November 2012-January 2014

次要结局

  • days of hospitalization(15 months)

研究者

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

maliwan oofuvong

Department of Anesthesiology

Prince of Songkla University

研究点 (1)

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