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临床试验/NCT04201860
NCT04201860已完成不适用

Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds of Blasting Gelatin: a Field Report During a Cave Accident

Emiliano Petrucci1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2016年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
Change from baseline haemostasis analysis at 2 hours

研究概览

简要总结

The aim of the study was to investigate the possible relationship about blood gas and bleeding disorders in healthy volunteers of blasters and no blasters groups of the Italian National Mountain and Cave Rescue who handled nitrogen compounds and nitroglycerine and then they were exposed to combustion products from an accidental uncontrolled detonation of micro-charges during a cave unblocking procedure.

详细描述

This was a field report of clinical data collected during an accidental uncontrolled detonation of micro-charges, while the cave unblocking procedure was performed by volunteers of blaster group and non blasters group of the Italian National Mountain and Cave Rescue, in a cave in Trieste (Italy; altitude entrance: 348 meters above sea level; total length: 413,5 meters; total depth of 307 meters).

Before going into the cave (Time 0), the following clinical data were collected: age, sex, body mass index; smoke (yes/no), heart rate, arterial blood pressure (mean arterial pressure), oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures.

After the accidental uncontrolled detonation of micro-charges, (Time 1) heart rate, arterial blood pressure, oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures were recorded in each volunteers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers of Italian National Mountain and Cave Rescue

排除标准

  • gas exchange disorders
  • quantitative abnormalities of coagulation assessment
  • qualitative abnormalities of coagulation assessment

结局指标

主要结局

Change from baseline haemostasis analysis at 2 hours

时间窗: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave

Under aseptic conditions, a venipuncture was performed: three mL of blood sample were used for the haemostasis measure, by using Rotational Thromboelastometry

Change from baseline arterial blood gases analysis at 2 hours

时间窗: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave

Under aseptic conditions, a puncture of radial artery was performed: one mL was tested for the blood gases analysis, by using i-STAT analyser.

次要结局

  • Change from baseline arterial blood pressure at 2 hours(10 minutes before going in to the cave and two hours after the volunteers come out from the cave)
  • Change from baseline pulse oxymetry at 2 hours(10 minutes before going in to the cave and two hours after the volunteers come out from the cave)
  • Change from Baseline heart rate at 2 hours(10 minutes before going in to the cave and two hours after the volunteers come out from the cave)
  • Change from baseline epitympanic temperature at 2 hours(10 minutes before going in to the cave and two hours after the volunteers come out from the cave)

研究者

发起方
Emiliano Petrucci
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emiliano Petrucci

Principal Investigator

San Salvatore Hospital of L'Aquila

研究点 (1)

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