POC Analysis of IO Blood Samples Within Critically Ill Patients

Critically Ill Clinical Trial

Official title:

Point-of-care Analyses of Intraosseous Blood Samples Within Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746496
• Other study ID #: 1234567890
• Status: Completed
• Start date: May 3, 2017
• Est. completion date: January 29, 2019

Study information

• Verified date: March 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to investigate whether point-of-care (POC) analysis of intraosseous (IO) blood samples from critically ill emergency patients are accurate enough for emergency decision making, in comparison with arterial point-of-care samples.

Description:

Intravenous access is sometimes difficult to achieve due to vasoconstriction or centralization of circulation. Feasible IO-access with power-driven device is a standard alternative method of vascular access for critically ill patients. It is still unclear whether results of IO samples agree with venous or arterial blood samples so that they could be used in clinical decision-making.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• need for point-of-care analysis

• need for intraosseous access

Exclusion Criteria:

• cardiac arrest

• ability to understand the consent issues in Finnish, Swedish or English

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Diagnostic Test:
• point-of-care laboratory analysis
POC analysis with i-STAT POC analyser from the intraosseous and arterial blood

Locations

Country	Name	City	State
Finland	FinnHEMS10, Emergency Medicine and Services, Helsinki University Hospital	Vantaa

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	FinnHEMS Oy

Country where clinical trial is conducted

Finland, 

References & Publications (5)

Bäckman S, Ångerman-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Veldhoen ES, de Vooght KM, Slieker MG, Versluys AB, Turner NM. Analysis of bloodgas, electrolytes and glucose from intraosseous samples using an i-STAT(®) point-of-care analyser. Resuscitation. 2014 Mar;85(3):359-63. doi: 10.1016/j.resuscitation.2013.12.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agreement between intraosseous (IO) and arterial POC analyses	agreement analysed with Bland-Altman method from IO and arterial blood samples, which have been analysed with iSTAT point-of care analyser for following parameters: Hb, pH, BE, HCO3, pO2, pCO2, glucose, Na, K, iCa	Samples are analysed immediately after the sample has been taken. Statistical analysis about the agreement performed when the whole data has been collected.