此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Safe Limits in Saturation (SLIM-study) (SLIM)

2018年10月16日 更新者：Angelique Spoelstra-de Man、Amsterdam UMC, location VUmc

A study consisting of a prospective and retrospective cohort in the ICU, ER and pulmonary department in a university hospital in Amsterdam and a teaching hospital in Alkmaar, the Netherlands.

The relationship between the oxygen saturation measured by pulse-oximetry and the arterial PaO2 is investigated in order to investigate which transcutaneous saturation values are safe when administering oxygen in relation to hyperopia and hypoxia.

研究概览

地位

完全的

条件

详细说明

This study consists of two parts a prospective and a retrospective part.

  1. Prospective part: Patients in the ICU, the emergency room and the pulmonary function department of the VU university medical centre will be included. Arterial blood gas analysis is a tool often used to determine PaO2 in regular care. When an arterial blood gas analysis is performed for regular patient care, the corresponding SpO2 is measured. Information such as blood pressure, heart rate, amount of administered fluids and shock-related-parameters are obtained from the patient files. For the ICU patients capillary refill, acra temperature and the mottling scores are examined. The peripheral flow index and temperature index is measured. When more arterial blood gas samples are drawn over time in one patient, multiple datasets can be included per patient, as long as the samples are drawn two hours apart.
  2. Retrospective part: Patients with a (suspected) pulmonary disease who underwent pulmonary function tests with arterial bloodgas sampling in the VU medical center and Medical Centre Alkmaar in the last 25 years. The PaO2 and corresponding SpO2 will be obtained from the test and parameters such as blood pressure, heart rate and administered oxygen will be retrieved from the databases with these test results.

研究类型

观察性的

注册 (实际的)

879

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 荷兰
    • Noord-Holland
      • Amsterdam、Noord-Holland、荷兰、1007 MB
        • VUMedicalCentre

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Prospective

  • ICU - VUmc: Critically ill patients, requiring invasive monitoring
  • Pulmonary function department - VUmc: Patients requiring a pulmonary function test with arterial bloodgas analysis.
  • ER VUmc: Patients presented at the shockroom or patients in the general ER, requiring arterial bloodgas analysis.

Retrospective

- Pulmonary function departments: Patients who underwent a pulmonary function test with arterial bloodgas analysis in the last 25 years.

描述

Inclusion criteria for all inclusions:

  • Age: 18>
  • Requiring arterial bloodgas analysis

Exclusion criteria for all inclusions:

  • Hyperbilirubinemia (>20 μmol/L)
  • CO-Hb (>1,5%)
  • MetHb (>1,5%)
  • Unreliable pulsatile SpO2 curve

Additional inclusion criteria:

- Prospective, ICU - VUmc: On mechanical ventilation. Arterial line in place.

Additional exclusion criteria:

  • Prospective, ICU - VUmc: On extracorporeal membrane oxygenation. Therapeutic hypothermia.
  • Retrospective, Pulmonary function departments: Uncertainty whether SpO2 was measured exactly during arterial bloodgas sampling.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
ICU-patients (prospective)
Critically ill patients (18 years and older) on mechanically ventilation who have an arterial line and require bloodgasanalysis for medical reasons
Emergency Department (prospective)
Patients (18 years and older), who are presented to the Emergency Department, and require bloodgasanalysis for medical reasons
Pulmonary department (prospective)
Patients (18 years and older) who visit the outpatient clinic of the pulmonary department for different pulmonary functional test and require bloodgasanalysis for medical reasons
Pulmonary department (retrospective)
Patients (18 years and older) who visited the outpatient clinic of the pulmonary department in the past of the VU medical centre in Amsterdam or the Medical Centre Alkmaar for different pulmonary functional test and required bloodgasanalysis for medical reasons

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Relation SpO2-PaO2
大体时间：Average of one week
To determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur
Average of one week

次要结果测量

结果测量
措施说明
大体时间
Factors influencing PaO2-Spo2 relation
大体时间：Average of one week
To identify factors influencing the relationship between SpO2 and PaO2, such as hemodynamics, peripheral circulation, shock and pH
Average of one week
Relation in SpO2-PaO2 in different populations
大体时间：Average of one week
To determine differences in the SpO2/PaO2 -relationship in different populations
Average of one week
Differences in relation in SpO2-PaO2 prospective versus retrospective
大体时间：Average of one week
To determine differences in the SpO2/PaO2 -relationship in a prospective and a retrospective cohort
Average of one week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Amsterdam UMC, location VUmc

调查人员

  • 研究主任：Angelique ME Spoelstra - de Man, Phd Md、Amsterdam UMC, location VUmc

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年12月1日

初级完成 (实际的)

2017年8月1日

研究完成 (实际的)

2017年8月1日

研究注册日期

首次提交

2015年11月30日

首先提交符合 QC 标准的

2016年1月25日

首次发布 (估计)

2016年1月28日

研究记录更新

最后更新发布 (实际的)

2018年10月18日

上次提交的符合 QC 标准的更新

2018年10月16日

最后验证

2018年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2014.524 (A2015.361)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅