Optimal Blood Sampling Site for Point of Care Lactate Assessment

Sponsor
University Hospitals, Leicester (Other)
Overall Status
Completed
CT.gov ID
NCT04291989
Collaborator
(none)
50
1
1
8
6.2

Study Details

Study Description

Brief Summary

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)

Condition or Disease Intervention/Treatment Phase
  • Device: Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This study aims to compare lactate levels from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepunctureThis study aims to compare lactate levels from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepuncture
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Optimal Blood Sampling Site for Point of Care Lactate Assessment
Actual Study Start Date :
Jul 18, 2018
Actual Primary Completion Date :
Mar 20, 2019
Actual Study Completion Date :
Mar 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 [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?

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Leicester Royal Infirmary Leicester Please Select United Kingdom LE1 5WW

Sponsors and Collaborators

  • University Hospitals, Leicester

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT04291989
Other Study ID Numbers:
  • Edge I.D - 90666
First Posted:
Mar 2, 2020
Last Update Posted:
Mar 2, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospitals, Leicester
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2020