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临床试验/NCT02607644
NCT02607644已完成不适用

Clinical Evaluation of Laryngeal Tube and Laryngeal Mask Airway for Cardiac Arrest Treatment in Emergency Ambulances in Singapore

Singapore General Hospital2 个研究点 分布在 1 个国家目标入组 965 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
965
试验地点
2
主要终点
successful intubation (number

研究概览

简要总结

Introduction: The laryngeal mask airway (LMA) is used as the primary airway by paramedics in Singapore Civil Defense Force's Emergency Ambulance Service (SCDF's EAS) in the management of out-of-hospital cardiac arrest, because endotracheal intubation requires skilled and experienced personnel, and local paramedics are not trained to this level of skill and competency. However, self-reported insertion success rates by paramedics in the field are currently only about 50-87%. Devices like the laryngeal tube have been shown to have higher placement success rates and fewer complications.

Aim: Investigators aim to evaluate the efficacy and safety of a new device, the Laryngeal Tube (LT), compared to the LMA. They hypothesize that the LT is superior to the LMA in terms of placement success rates by paramedics in SCDF's EAS, and is associated with fewer adverse events.

Methodology: Investigators propose to conduct a prospective, longitudinal multi-centre randomized trial comparing LMA and LT in patients with cardiac arrest (medical or traumatic) managed by SCDF EAS. The trial will recruit 1,015 eligible patients presenting to SCDF irrespective of destination hospital over a period of 1 year to detect an expected 15% difference in placement success rate. Currently the LMA is used as standard of care by SCDF's EAS in patients with cardiac arrest.

Results: Besides the primary outcome, the secondary outcomes of dislodgment rates, time to placement, number of attempts and adverse events will be analyzed and will be useful in guiding future SCDF cardiac arrest protocols.

详细描述

Endotracheal intubation (ETI) is considered the gold standard of airway management as it a definitive airway providing ventilation and prevention of aspiration in a patient unable to protect his airway. However, it can only be used by skilled, experienced personnel and can be difficult in the pre-hospital setting. It may also result in unrecognized oesophageal intubation. Currently ETI is not recommended for Singapore Civil Defence Force (SCDF) ambulances by MHA (Medical Advisory Committee) and local paramedics were not trained to this level of skill and competency. Furthermore, there has been reduced emphasis on early tracheal intubation unless achieved by highly skilled individuals to minimise interruption to chest compressions according to the 2010 resuscitation guidelines.

In view of the above reasons, ETI is not recommended by the Ministry of Home Affair's Medical Advisory Committee (MAC). Instead, the disposable laryngeal mask airway (LMA) has been used as the primary airway by paramedics in SCDF's Emergency Ambulance Service (EAS) in the management of both medical and traumatic cardiac arrest patients and is approved by the MAC for use in both adults and children.

However there can still be complications with the LMA such as incomplete seal and partial airway obstruction from mask misplacement or kinking. In addition, SCDF's self-reported success rate of LMA is only 50-87% .Hence there was a need to explore other alternatives to the LMA. The American Heart Association (AHA) recommends advanced airway adjuncts such as the Laryngeal Tube (LT) and Oesophageal-tracheal tube (Combitube) for alternative airway strategies. Other devices include the pharyngeaotracheal lumen airway and the oesophageal obdurator airway - oesophageal gastric tube airway (EOA-EGTA).

Investigators have chosen the LT as an alternative adjunct because it has a higher insertion success rate than LMA. It also has low complication such as regurgitation, vomiting and dislodgement and comes in sizes to accommodate both paediatric and adult. Method of use is quite simple as it can be inserted blindly into the oropharynx and pushed in until resistance is felt or device is fully inserted as denoted by the markings on the device.

Our long term objective is to improve existing EAS's cardiac arrest protocol and placement success rate and to lower complications and adverse events rates in out of hospital cardiac arrest. The result of the study will be reviewed by SCDF's Medical Advisory Committee (MAC). The results can also determine the choice of rescue airways used in the hospitals eg operating theatres, emergency departments, endoscopy rooms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
13 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 13-100 years old
  • Cardiac arrest (medical or traumatic)
  • Adjunct airway device is needed

排除标准

  • Resuscitation is not indicated (e.g. decapitation, rigor mortis, dependant lividity)
  • Pregnant women
  • Conscious, intact gag reflex
  • Known ingestion of caustic substances

研究组 & 干预措施

Laryngeal Tube (LT)

Experimental

VBM Laryngeal Tube (Intervention)

干预措施: Laryngeal Tube (LT) (Device)

Laryngeal Mask Airway (LMA)

Active Comparator

Laryngeal Mask Airway (LMA)

干预措施: Laryngeal Mask Airway (LMA) (Device)

结局指标

主要结局

successful intubation (number

时间窗: 1 year

Confirm clinically by auscultation and equal chest rise on bagging

次要结局

  • number of placement attempts required(10 minutes)
  • Dislodgement rates(1 hour)
  • Time to successful placement of airway device(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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