NCT03746496

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

September 27, 2018

Last Update Submit

March 6, 2019

Conditions

Keywords

intraosseousblood gas analysisemergency medicinecritically illpoint-of-care

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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.)

Diagnostic Test: point-of-care laboratory analysis

Interventions

POC analysis with i-STAT POC analyser from the intraosseous and arterial blood

pre-hospital emergency patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency patients, which are met by the helicopter emergency unit during their normal tasks

You may qualify if:

  • need for point-of-care analysis
  • need for intraosseous access

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FinnHEMS10, Emergency Medicine and Services, Helsinki University Hospital

Vantaa, Finland

Location

Related Publications (5)

  • 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.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jouni Nurmi, M.D. Ph D

    University of Helsinki, Helsinki University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docent

Study Record Dates

First Submitted

September 27, 2018

First Posted

November 19, 2018

Study Start

May 3, 2017

Primary Completion

January 29, 2019

Study Completion

January 29, 2019

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations