Optimal Blood Sampling Site for Point of Care Lactate Assessment

February 28, 2020 updated by: University Hospitals, Leicester
The study was to compare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT >/= 7)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following a hip fracture, surgical treatment is advocated to improve pain and mobility. Most patients are elderly and a majority of them are frail. Current best practice tariff and National Institute for health and care excellence guidelines recommends that all those patients who undergo an operation should be performed within 36 hours from the time of injury to optimise recovery and function. The patients need to be medically optimised to undergo a major operation to have their hip fracture fixed. The adequacy of resuscitation is monitored by several clinical and biochemical markers. One of the important markers of resuscitation is serum lactate levels. This is used routinely in polytrauma patients. (Moran and Forward, 2012) The initial interest in lactate in hip fracture patients was based on the philosophy that a hip fracture in a frail elderly patient may be equivalent to a polytrauma in a young fit patient. Subsequently, high serum lactate levels on admission in hip fracture patients have been shown to be associated with higher mortality1. However, at present, this is not routinely monitored in hip fracture patients. Measurement of serum lactate levels presents logistics difficulties, as the blood sample has to be taken to an analyser and analysed within 20 minutes. Hence the investigators want to use a point of care electronic hand held device - the Lactate Pro 2. The investigators have already tested this device against the laboratory analysers and it has been proven to be accurate. However in preliminary testing the investigators found a significant difference between fingertip and earlobe samples in volunteers. The volunteers do not represent our population of interest, which are hip fracture patients. The investigators aim is to determine which sample site; earlobe or fingertip, for Lactate Pro 2 testing best matches venous forearm samples upon which the association of higher mortality with high lactate was based.

Any risk to the patients participating in this study would be very small. The inclusion criteria to participate in this research study is a patient who has had a recent hip fracture awaiting surgery with a Mental Test score of 7/10 or above and is able to consent.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Please Select
      • Leicester, Please Select, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female, aged 18 years or above.
  • Diagnosed with an acute hip fracture.
  • Have a mental test score of 7/10 or greater on assessment during admission.
  • Participant is willing to consent to the study.

Exclusion Criteria:

  • The participant will not enter the study if

    1. There are Injuries other than isolated hip fracture
    2. Age <18 years
    3. They are not willing to consent for the study
    4. They have a mental test score less than 7/10 at the time of admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Earlobe and Finger Prick versus venous blood lactate sampling
Compare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT >/= 7)
Device: Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device
This study aims to compare lactate levels using the Lactate Pro 2 device from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger prick blood sample and earlobe prick blood sample compared to forearm venepuncture blood sample to measure blood Lactate levels in mmol/l using the point of care Lactate-Pro2 device
Time Frame: The investigators aim to recruit 50 acute hip fracture patients over a time period of upto 6 months for our study. The outcome will be measured only once and recorded at the point of care for each patient.
Which of the two sample sites - finger or earlobe most closely matches the forearm venepuncture blood sample for measuring blood lactate levels?
The investigators aim to recruit 50 acute hip fracture patients over a time period of upto 6 months for our study. The outcome will be measured only once and recorded at the point of care for each patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Investigators

  • Principal Investigator: GANAPATHY RAMAN R Perianayagam, FRCS (Orth), University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Edge I.D - 90666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant date for primary outcomes will be made available

IPD Sharing Time Frame

for 6 months after publication of the study

IPD Sharing Access Criteria

Data access will be reviewed by an external review panel. Requestors will be required to sign a Data Access Agreement form.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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