跳至主要内容
临床试验/NCT04279860
NCT04279860Unknown不适用

Foreign Body Airway Obstruction, Incidence, Survival EMS-treatment and First Aid Treatment by Laypersons

Emergency Medical Services, Capital Region, Denmark1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
30-day Survival

研究概览

简要总结

Background:

Foreign body airway obstruction (FBAO) is often described as an uncommon cause of Out of Hospital Cardiac Arrest (OHCA) accounting for approximately 1.4% of all OHCA. Reported incidents rates of FBAO causing cardiac arrest are unclear, and first aid by layperson are not well described.

The aim of the epidemiological part of the study is:

  • to investigate information on actions taken by EMS-personnel and laypersons
  • to investigate outcomes of hypoxic Cardiac Arrest due to foreign body airway obstruction in Denmark
  • to increase overall survival. propose new guidelines and strategies to increase survival from OHCA caused by FBAO.

The aim of advanced text-string search algorithm part of the study is

  • To investigate if an advanced text-string search algorithm can identify FBAO in medical records with high sensitivity

Methods:

National data will be collected from the verified 2016-2019 Danish OHCA register, and cases with FBAO prior to OHCA will selected via a direct marking by external validation and advanced text search. Patients reported as indisputably deceased (late signs of death) was excluded. Incidence rates per 100.000 citizens, survival rates to hospital and first aid actions by layperson are presented.

A pilot study have been conducted in regional data from 2016-2019 and the study group have concluded that, a national study is feasible with the current amount of data and the used methodology.

Expected outcome:

This study will enable targeted campaigns aimed at increasing survival from OHCA caused by FBAO. Potential campaigns might target the food items provided to potential vulnerable groups and guide focus for first aid recommendations. Further, with a deeper understanding of which airway management procedures most often are successful, it will be possible to improve EMS treatments of vulnerable groups.

Finally, a novel method of extracting information from the electronic medical records will be developed creating the foundation for future works on other prehospital conditions

详细描述

Background Foreign body airway obstruction is a partial or complete blockage of airways, due to a foreign body (for example food, toys, coins etc.) Blocked airways will untreated result in cardiac arrest by hypoxia.

Previous research describes foreign body airway obstruction as an uncommon cause of Out-of-Hospital Cardiac Arrest (OHCA) accounting for approximately 1.1-1.4% of all OHCA. Reported incident rates of foreign body airway obstruction (FBAO) causing hypoxic cardiac arrest are unclear. It is reported to be as high as 11 per 100,000 person-years, comprising 10% of all OHCA, and neither Emergency Medical Services (EMS) treatment or first aid by layperson are well described. When organizing prevention campaigns for serious FBAO leading to cardiac arrest, knowledge on items with poor outcomes, vulnerable age-groups and treatments (appropriate and non-appropriate) initiated by both laypersons and EMS-personnel is essential. Previous studies suggest a bimodal distribution of FBAO compromised of the very young ingesting toys or other non-food related items (coins, balloons etc.) and elderly ingesting mainly food items . Several comorbidities are well documented to be over-represented in fatal cases in FBAO, notably cerebral infarction; dementia; schizophrenia; depression and Parkinson's disease .

However, FBAO leading to hypoxic cardiac arrest is a reversible cause that can easily be treated, and therefore prevented. Hence, hypoxic cardiac arrest due to FBAO provides a great potential for increasing overall survival from OHCA if efficient campaigns are implemented to provide the correct diagnosis, to facilitate prompt treatment from both EMS-personnel and laypersons. Such campaigns must be guided by evidence, realistic estimates of population and reliable baseline measures to evaluate effect.

Although, only minor studies present data from arrival to the hospital, several studies imply that the most common food items involved in FBAO is meat, bread, rice cakes, fruits and rice. There is a need to include prehospital data in a national study, to include relevant treatment administered by EMS or laypersons educated in first aid. A study by Igarashi et al. implies that the actions of laypersons has a significant impact on survival and that they, more often than not, use the Heimlich maneuver of abdominal thrust. However, only few patients in this study (12%) is treated by laypersons. More knowledge on the actions of bystanders are needed. The European Resuscitation Council currently recommend laypersons to deliver five back blows followed by an abdominal thrust/Heimlich maneuver if a person is suffering from severe FBAO (unable to cough). For health care personnel, including EMS, the MaGill forceps is first-choice when removing foreign bodies, with significantly higher survival rates reported. However, a complete report of all airway treatments and additional factors known to impact survival have not yet been reported.

There is approximately 5.400 OHCA annually in Denmark. The most updated 30-survival (2018) is 15,7%. This is among some of the highest in the world. A multitude of efforts and campaigns are targeting the different aspects of OHCA to improve survival. Although not yet verified, several sources report that approximately 3-4.5% of the entire Danish population (approximately 200.000-255.000 citizens) attend certified cardio pulmonary resuscitation (CPR) and automatic external defibrillator (AED) courses annually. These courses supposedly include recognition and treatment of FBOA.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • All persons suffering from out-of-hospital cardiac arrest (OHCA) in Denmark from 2016-2020 identified in the verified danish OHCA register.

排除标准

  • Patients reported as indisputably deceased (late signs of death) will be excluded.

结局指标

主要结局

30-day Survival

时间窗: through study completion, an average of 1 year

Survival will be defined as ROSC at the time of hospital admission. Further the investigators will include rates for 30-day survival derived with data from the National Patient Registry.

State at hospital admission

时间窗: through study completion, an average of 1 year

Defined as the case state on arrival at the hospital as either; ROSC or ongoing CPR.

Incidence rate

时间窗: through study completion, an average of 1 year

Incidence rate of out-of-hospital cardiac arrest caused by foreign body airway obstruction per 100.000 citizens

Return-of-spontaneous-circulation (ROSC)

时间窗: through study completion, an average of 1 year

ROSC will be defined as cases achieving ROSC anytime between recognition of the event and termination (defined as either hospital admission og declaration of death by EMS-personnel).

次要结局

未报告次要终点

研究者

发起方
Emergency Medical Services, Capital Region, Denmark
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验