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临床试验/NCT03994419
NCT03994419Unknown不适用

PErioperAtive CHildhood obesitY (PEACHY): A Prospective Observational Cohort Study Investigating the Proportion of Overweight and Obese Children Presenting for a Procedure Under General Anaesthesia in the UK and the Incidence of Perioperative Adverse Outcomes in This Patient Group

University Hospital Southampton NHS Foundation Trust0 个研究点目标入组 8,000 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
8,000
主要终点
Proportion of overweight and obesity in UK children attending for surgery

研究概览

简要总结

The incidence of childhood obesity is at epidemic levels and increasing in the UK. Obese adults are considered a high-risk group of patients for general anaesthesia with published national guidelines on the best practice management. The proportion of children presenting for a procedure under general anaesthesia in the UK who are overweight or obese is currently unknown.

Obese children are perceived to be at greater risk of complications from general anaesthesia. Previous non-UK studies suggest they take longer to recover from anaesthesia, require more medications to combat nausea and vomiting and are at greater risk of complications that may threaten their airway and breathing.

This study involves reviewing the anaesthetic care record and patient notes to collect information relating to general anaesthesia and basic demographic data in children aged 2-16 years presenting for a procedure under general anaesthesia.

The aims of this study are to establish the prevalence of obesity in the paediatric surgical population (i.e. the proportion of children attending UK hospitals for procedures under general anaesthesia who are overweight or obese) and to ascertain whether obese children are at increased risk compared to their healthy weight counterparts.

This information will be used with the goal of reducing avoidable harm both at national and local level in the future.

详细描述

IRAS 248493 REC 18/WM/0394 NIHR CPMS ID 40368

Hypotheses

  1. Overweight and obese children commonly present for procedures under general anaesthesia.
  2. Obese children are at higher risk of perioperative adverse events compared to their healthy-weight counterparts.
  3. There is wide variation in paracetamol drug dosing amongst obese children.
  4. Obese children may be more likely to present for certain surgery compared to their healthy-weight counterparts.

This observational cohort study will take place in NHS hospitals in the UK with trainee anaesthetists affiliated to the Paediatric Anaesthesia Trainee Research Network (PATRN). To increase coverage of sites in the UK, the project will be advertised through other trainee research networks including Research and Audit Federation of Trainees (RAFT) and through the Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI) linkmen.

Each hospital taking part will have a nominated anaesthetic consultant and trainees who will act as local investigators collecting data. Data will be collected for all children aged 2-16 years weighing >12kg presenting for a procedure involving general anaesthesia during the defined study period. This will be one week (7 consecutive days). Using previous PATRN audit projects as a guide, we aim to enrol approximately 90 local sites which will give an estimated total of 7590 children attending for a procedure under general anaesthesia during the study period.

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
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children aged greater than or equal to two years and less than 16 years presenting for a procedure under general anaesthesia.
  • Elective cases, day case and emergency cases will all be included.
  • Private cases being undertaken in NHS hospitals will be included.
  • MRI, radiology, oncology and dental cases will be included provided the patient receives a general anaesthetic.

排除标准

  • Procedures performed under sedation or local anaesthesia.
  • Children aged less than two years since the 0-24 month age group has separate growth charts, which are not currently recommended for interpretation of BMI.
  • Children weighing less than 12kg as these are not included on the growth charts for interpretation of BMI.
  • Children requiring general anaesthesia purely as part of intensive care treatment.
  • Children who are already anaesthetised in the intensive care setting being transferred for a scan or procedure without any intervention to their airway planned.
  • Children 16 years or more may be counted as children in some hospitals but not for the purposes of this study.

结局指标

主要结局

Proportion of overweight and obesity in UK children attending for surgery

时间窗: One week study period

The proportion of overweight and obesity in UK children aged 2-16 years attending hospitals for a procedure under general anaesthesia.

次要结局

  • Adverse events(One week study period)
  • Paracetamol dosing variation(One week study period)
  • Surgery types(One week study period)
  • Comparison with the UK National Child Measurement Programme(One week study period)

研究者

申办方类型
Other
责任方
Sponsor

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