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临床试验/NCT04764799
NCT04764799已完成不适用

HEAVEN Criteria: a Monocentric Prospective Observational Study to Validate the Prediction of Difficult Airway for In-Hospital Emergency Airway Management

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 2,800 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,800
试验地点
1
主要终点
Patients with difficulty of intubation

研究概览

简要总结

The HEAVEN criteria were found valid to predict difficult airways during preclinical emergency intubations in a retrospective study. The acronym stands for Hypoxemia, Extremes of size, Anatomic abnormalities, Vomit/blood/fluid, Exsanguination/anaemia, and Neck mobility issues. This is a monocentric prospective observational study to assess the validity of the HEAVEN criteria in the in-hospital setting at a level I adult and pediatric emergency university-based hospital.

详细描述

Emergency intubations are prone to present a difficult airway. A difficult airway can lead to prolonged intubation time and to hypoxemia in situations where oxygenation is not possible that can finally result in hypoxic cardiac arrest and irreversible brain damage caused by hypoxic ischemic encephalopathy.

Tools to predict difficult airways are rather poor concerning specificity and sensitivity. A score to predict difficult airway developed in the pre-clinical setting are the HEAVEN criteria. The acronym HEAVEN stands for: Hypoxemia, Extremes of size, Anatomic abnormalities, Vomit/blood/fluid, Exsanguination/anaemia, and Neck mobility issues and does not need patients' cooperation. It has been recently validated in the pre-clinical emergency setting and was found to be useful.

The study aim is to evaluate if the HEAVEN criteria are suitable to be used to predict difficult airway in in-hospital emergency intubation to finally increase patients' safety during rapid sequence induction (RSI).

This prospective observational single-centre study in emergency intubation will consecutively recruit all patients of all ages who need RSI due to their medical condition performed by the staff of the Department of Anaesthesiology and Pain Medicine at the Bern University Hospital. We will record data that are gathered during routine patient care and stored primarily in the departmental anaesthesia information systems.

The primary objective is to validate if the HEAVEN criteria, an existing prehospital difficult airway prediction tool, is able to predict airways difficulties during RSI in the clinical in-hospital setting. The secondary objective is, to assess the subcomponent of the HEAVEN criteria and if differences and adaptations are needed comparing it to the prehospital setting.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All consecutive patients of all ages who need an in-hospital rapid sequence intubation (RSI) performed by the staff of the Department of Anesthesiology and Pain Medicine
  • Given general consent or delayed obtained general consent after the procedure
  • English, German or French speaking patients

排除标准

  • Patients without informed consent

结局指标

主要结局

Patients with difficulty of intubation

时间窗: 1 hour

Rated on a scale by the airway manager: easy, difficult, not possible

Patients with first-attempt success rate of RSI

时间窗: 1 hour

Every attempt starts with the insertion of a laryngoscope blade over the lips and ends with a blocked tube in the trachea and measuring of carbon dioxide (CO2)

次要结局

  • Patients with use of vasoconstrictors during RSI(1 hour)
  • Patients with first-attempt success without desaturation SpO2 <92% during RSI(1 hour)
  • Lowest and highest recorded value of patients' blood-pressure (BP) during RSI(1 hour)
  • Patients with use of devices/ techniques for intubation(1 hour)
  • Endotracheal tube (ETT)(1 hour)
  • Lowest and highest recorded value of patients' heart rate (HR) during RSI(1 hour)
  • Overall success rate of rapid sequence induction (RSI)(1 hour)
  • Lowest and highest recorded value of patients' oxygen saturation (SpO2) during RSI(1 hour)
  • Patients with use and type of neuromuscular blockage agent(1 hour)
  • Type of planned procedure(1 day)
  • Place of intubation(1 day)
  • Level of airway manager(1 hour)
  • Patients with suspicion of aspiration during RSI(1 day)
  • Total attempts of intubation in a patient(1 hour)
  • Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient(1 hour)
  • Patient's demographics(1 hour)
  • Time of intubation(1 hour)
  • Patients with airway-related injuries like blood, damage to tissue, lips or teeth caused directly during intubation(1 hour)
  • Patients with airway-related complains like hoarseness or problems with swallowing until 24 hours after intubation reported subjectively by the patient(1 day)

研究者

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

Thomas Riva

Principal Investigator

Insel Gruppe AG, University Hospital Bern

研究点 (1)

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