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临床试验/NCT04206566
NCT04206566已完成不适用

PHASTER - Pre-Hospital Advanced Airway Management STudying Expedited Routines

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2020年3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
430
试验地点
2
主要终点
First pass success rate on prehospital tracheal intubation

研究概览

简要总结

In the Scandinavian and Swiss HEMS critical care teams, the prehospital tracheal intubations (TI) are performed by airway experts with high success rates and low rates of complications. Due to environmental conditions these are today frequently performed in-cabin before take-off. There are so far no published data on comparing outside and in-cabin TI under these circumstances.

This will therefore be the first prospective study comparing prehospital TIs outside or incabin, performed by airway experts.

详细描述

Background Seriously ill or injured patients might require prehospital TI, which is a potentially lifesaving intervention. Performing TI in a prehospital context differ from the preconditions inhospital due to environmental and technical aspects and resources available (3). Today there is a consensus that prehospital critical care should at least be on the same standards as in-hospital care. The trend therefore has been towards more rigorous safety precautions introducing Standard Operating Procedures (SOP) including 360oaccess to patients with all equipment at close hand brought out from the helicopter or the ambulance and long challenge-response lists. This will shift focus towards adherence to SOPs instead of tailoring the sequence of procedures according to circumstances and patient needs. An experienced operator can plan and communicate appropriate actions from a risk-benefit perspective in a stressful situation. Prehospital interventions have to be time effective, especially where short on-scene times are preferable in time-critical conditions such as uncontrolled internal haemorrhage and traumatic brain injuries.

A recent Nordic multicentre study, PHAST, shows that emergency systems staffed with highly experienced anaesthetists can perform prehospital TI with high success rates, low incidence of complications and short on-scene times. Due to environmental factors, weather and light conditions in the Scandinavian countries, it is not always favourable to perform TI outside the helicopter or ambulance, with 360o -access. Technical aspects in-helicopter/in-ambulance such as access to better suctioning and stretcher positioning, can influence the operator's decision on where to perform the TI. Whether the location of the TI affects the outcome has not yet been studied. A recent experimental mannequin study, SPRINT, suggests that in-cabin intubations can offer equal to, or even better conditions than out of cabin and can shorten on-scene time. To investigate whether this applies to real life conditions, a prospective large-scale clinical study must be done.

Performing prehospital TI is dependent on a well-functioning team where the operator has an assistant backing up during the procedures. The assistants' level of airway experience and the teams' accumulated experience working together has not been studied earlier.

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

  • Patients in need of prehospital drug-assisted intubation.

排除标准

  • All cases where prehospital TI is performed without the use of any drugs.

结局指标

主要结局

First pass success rate on prehospital tracheal intubation

时间窗: While handling the patient in need for tracheal intubation

Successful intubation is defined as the endotracheal tube verified in the trachea. Prehospital intubations are performed outside the hospitals by ambulance helicopter personnel.

次要结局

  • Ground time(While handling the patient case)
  • Scene time 2(While handling the patient case)
  • Perceived difficulty of tracheal intubation(While handling the patient case)
  • Prehospital mortality(While handling the patient case)
  • Scene time 1(While handling the patient case)
  • Complications related to the drug assisted intubation(While handling the patient case)
  • Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance)(While handling the patient case)
  • Time to perform tracheal intubation(While handling the patient case)
  • Number of tracheal intubation attempts(While handling the patient case)

研究者

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

Mikael Gellerfors

Head of Research & Development, Swedish Air Ambulance (SLA)

Karolinska Institutet

研究点 (2)

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