POC Analysis of IO Blood Samples Within Critically Ill Patients
NCT ID: NCT03746496
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2017-05-03
2019-01-29
Brief Summary
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Detailed Description
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After intraosseous access has been established for fluid resuscitation or medication, a common practice is to aspirate a small amount of blood to verify the proper location of the IO-needle.
POC-testing can provide emergency physicians or paramedics with important information about the patients. Could bone marrow samples be used for POC-testing instead of arterial or venous blood for emergency treatment decision-making or patient allocation?
Several animal and human studies have been published to investigate the correlation between IO versus venous or arterial blood values. Investigators of this study have performed a study in healthy volunteers and discovered that there is a good agreement for some laboratory parameters (pH, gluc, lact), but for K the agreement is poor. Our study group has as well performed a study in critically ill animals investigating the agreement during cardiac arrest and resuscitation. Te evidence about critically ill people is still week.
Aim of this study is to analyze the reliability of analysis of IO samples compared to arterial blood samples within critically ill adult emergency patients.
The hypotheses of this study are:
1. Principally, it is possible to analyze IO blood samples with a POC device.
2. The results are reliable enough to guide emergency treatment.
If both hypotheses prove to be true, the method can be immediately used in emergency medical situations, e.g. in searching for reversible causes of cardiac arrest.
Setting
Prospective, observational study with 35 prehospital emergency patients. The IO-samples are collected from the small amount of blood, which is aspirated from intraosseous space to confirm the correct needle placement. The IO needles are inserted to the patients for emergency treatment, not because of the study. Critically ill patients, to whom emergency doctors are inserting an intraosseous needle for emergency fluid or drug treatment, are included in the study.
Samples will be analyzed by using an i-STAT point of care analyzer (i-STAT® handheld, Abbot Point of Care Inc. U.S.A) using CG8+ cartridges to analyse Hb, Na, K, pH, pCO2, pO2, TCO2, HCO3, BE, and SpO2. The reliability of the results comparing the IO and arterial samples will be tested with Bland-Altman method by calculating the bias with 95% confidence intervals.
Ethical issues
The ethical committee of Medical Faculty of University of Helsinki has approved the research. Informed consent is waived.
Time plan
The samples will be collected during years 2017 - 2019. The analysis will be performed in the end of the year 2019.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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pre-hospital emergency patients
Patient in a need of an IO-access. Patient in a need of point-of-care laboratory analysis. Over 18 years. Alive (no Cardiac arrest.)
point-of-care laboratory analysis
POC analysis with i-STAT POC analyser from the intraosseous and arterial blood
Interventions
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point-of-care laboratory analysis
POC analysis with i-STAT POC analyser from the intraosseous and arterial blood
Eligibility Criteria
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Inclusion Criteria
* need for intraosseous access
Exclusion Criteria
* ability to understand the consent issues in Finnish, Swedish or English
18 Years
ALL
No
Sponsors
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FinnHEMS Oy
UNKNOWN
Helsinki University Central Hospital
OTHER
Responsible Party
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Jouni Nurmi, MD
Docent
Principal Investigators
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Jouni Nurmi, M.D. Ph D
Role: PRINCIPAL_INVESTIGATOR
University of Helsinki, Helsinki University hospital
Locations
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FinnHEMS10, Emergency Medicine and Services, Helsinki University Hospital
Vantaa, , Finland
Countries
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References
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Jousi M, Laukkanen-Nevala P, Nurmi J. Analysing blood from intraosseous access: a systematic review. Eur J Emerg Med. 2019 Apr;26(2):77-85. doi: 10.1097/MEJ.0000000000000569.
Jousi M, Saikko S, Nurmi J. Intraosseous blood samples for point-of-care analysis: agreement between intraosseous and arterial analyses. Scand J Trauma Resusc Emerg Med. 2017 Sep 11;25(1):92. doi: 10.1186/s13049-017-0435-4.
Backman S, Angerman-Haasmaa S, Jousi M, Siitonen S, Salmela K. ABO and D typing and alloantibody screening in marrow samples: relevance to intraosseous blood transfusion. Transfusion. 2018 Jun;58(6):1372-1376. doi: 10.1111/trf.14557. Epub 2018 Mar 1.
Tallman CI, Darracq M, Young M. Analysis of intraosseous blood samples using an EPOC point of care analyzer during resuscitation. Am J Emerg Med. 2017 Mar;35(3):499-501. doi: 10.1016/j.ajem.2016.12.005. Epub 2016 Dec 12.
Veldhoen ES, de Vooght KM, Slieker MG, Versluys AB, Turner NM. Analysis of bloodgas, electrolytes and glucose from intraosseous samples using an i-STAT((R)) point-of-care analyser. Resuscitation. 2014 Mar;85(3):359-63. doi: 10.1016/j.resuscitation.2013.12.002. Epub 2013 Dec 31.
Other Identifiers
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1234567890
Identifier Type: -
Identifier Source: org_study_id
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