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临床试验/NCT04987411
NCT04987411Unknown不适用

Detection of Exhaled Methane Levels for the Recognition and Monitoring of Hemorrhagic Shock - Study Protocol for a Prospective Observational Study

Szeged University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Association between exhaled methane levels and sublingual microcirculation

研究概览

简要总结

This prospective observational study aims to test the efficacy of the continuous measurement of exhaled methane levels in monitoring the hemodynamic state of severely injured, bleeding trauma patients.

详细描述

This prospective observational study aims to test the efficacy of the continuous measurement of exhaled methane levels in monitoring the hemodynamic state of severely injured, bleeding trauma patients. Our inclusion criteria require an age of 18 years or greater, an Injury Severity Score (ISS) of 16 or greater, transport directly from scene, intubation on scene or upon arrival, hemorrhage confirmed with eFAST or CT, and signed consent from patient surrogates. Exhaled methane concentrations and indicators of blood loss and shock (vital signs: systolic blood pressure, heart rate; blood gas and laboratory markers: base deficit, lactate, hemoglobin, hematocrit; videomicroscopic image of sublingual microcirculation) will be recorded in pre-determined time points during the first 72 in-hospital hours. The relation between exhaled methane levels and indicators of shock will constitute our primary outcome measures. The association of methane concentrations with clinical outcomes (transfusion need, mortality) will serve as secondary outcomes.

研究设计

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

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

  • injury severity score (ISS)≥16
  • intubated on scene or upon arrival
  • transported directly from scene to the Emergency Department of the University of Szeged
  • hemorrhage confirmed with eFAST or CT
  • consent signed by patient surrogate

排除标准

  • 未提供

结局指标

主要结局

Association between exhaled methane levels and sublingual microcirculation

时间窗: First 72 in-hospital hours

We intend to investigate the relation between exhaled methane concentrations and sublingual microcirculation.

Association between exhaled methane levels and vital signs

时间窗: First 72 in-hospital hours

We intend to investigate the relation between exhaled methane levels and systolic blood pressure and heart rate.

Association between exhaled methane levels and blood gas and laboratory markers

时间窗: First 72 in-hospital hours

We intend to investigate the relation between exhaled methane levels and blood gas and laboratory markers (base deficit, lactate, hemoglobin, hematocrit).

次要结局

  • Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusion(First 72 in-hospital hours)
  • Association between exhaled methane levels and mortality(First 72 in-hospital hours)

研究者

发起方
Szeged University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petra Hartmann MD Ph.D.

M.D., Ph.D.

Szeged University

研究点 (1)

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