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临床试验/NCT03784664
NCT03784664已完成不适用

Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas

Assistance Publique - Hôpitaux de Paris8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月20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
100
试验地点
8
主要终点
Pain score: Visual Analog Scale

研究概览

简要总结

Blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas exchange disorders (using PaO2 and PaCO2). This examination can be taken from both venous and arterial sample and its analysis depends on the type of blood sample. Currently, several studies have already shown the existence of a good correlation of pH and bicarbonates level between a venous and arterial sample. Thus, when this examination is prescribed for the purpose of highlighting and analyzing an acid-base disorder, venous blood gas is theoretically as efficient as arterial blood gas.

Due to the lack of evidence of benefit for the patient or the health care team of a venous blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia, arterial blood gas is currently the standard of care for the analysis of acid-base disorders. Indeed, among the university hospitals affiliated to the Paris Diderot University, the emergency departments carry out in their vast majority (4 of 5 E.D.) arterial blood gases. Demonstration of the superiority of veinous sample over arterial sample regarding pain could substantially modify current practices.

The investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal oxygen saturation measured by plethysmography), the realization of a venous blood gas for the evaluation of the acid-base balance in the context of emergencies is less painful for patients, simpler for the health care team and provides sufficient biochemical information for the doctor in comparison with an arterial blood gas.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • necessity of blood gas analysis
  • age > 18 yo
  • SpO2>95% without supplemental oxygen
  • no altered level of consciousness: Glasgow Coma Scale=15

排除标准

  • Patient under guardianship or curatorship
  • confusional state or patient unable to understand the protocol
  • no social security

结局指标

主要结局

Pain score: Visual Analog Scale

时间窗: Immediately after blood gas sample

Pain is self-completed by the patient using a Visual Analog Scale. Visual Analog Scale for Pain is a continuous scale comprised of a line of 100 mm grading pain intensity anchored by "no pain" (score 0) and "worst imaginable pain" (score 100)

次要结局

  • Quality of information provided by the blood gas analysis: four levels likert scale(Immediately after having received blood gas analysis results)
  • Number of attempts needed to obtain a blood gas sample(Immediately after blood gas sample)
  • Number of different operators needed to obtain a blood gas sample(Immediately after blood gas sample)
  • Ease of blood gas sampling procedure(Immediately after blood gas sample)
  • Failure of the blood gas sampling procedure(Immediately after blood gas sample)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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