Optimal Blood Sampling Site for Point of Care Lactate Assessment
Primary Purpose
Blood Lactic Acid Increased, Hip Fractures
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device
Sponsored by
About this trial
This is an interventional diagnostic trial for Blood Lactic Acid Increased focused on measuring BLOOD LACTATE, EARLOBE SAMPLE, FINGER PRICK SAMPLE
Eligibility Criteria
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
- There are Injuries other than isolated hip fracture
- Age <18 years
- They are not willing to consent for the study
- They have a mental test score less than 7/10 at the time of admission.
Sites / Locations
- Leicester Royal Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Earlobe and Finger Prick versus venous blood lactate sampling
Arm Description
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)
Outcomes
Primary Outcome Measures
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
Which of the two sample sites - finger or earlobe most closely matches the forearm venepuncture blood sample for measuring blood lactate levels?
Secondary Outcome Measures
Full Information
NCT ID
NCT04291989
First Posted
February 26, 2020
Last Updated
February 28, 2020
Sponsor
University Hospitals, Leicester
1. Study Identification
Unique Protocol Identification Number
NCT04291989
Brief Title
Optimal Blood Sampling Site for Point of Care Lactate Assessment
Official Title
Optimal Blood Sampling Site for Point of Care Lactate Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Lactic Acid Increased, Hip Fractures
Keywords
BLOOD LACTATE, EARLOBE SAMPLE, FINGER PRICK SAMPLE
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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 venepuncture
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Earlobe and Finger Prick versus venous blood lactate sampling
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
Which of the two sample sites - finger or earlobe most closely matches the forearm venepuncture blood sample for measuring blood lactate levels?
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
There are Injuries other than isolated hip fracture
Age <18 years
They are not willing to consent for the study
They have a mental test score less than 7/10 at the time of admission.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GANAPATHY RAMAN R Perianayagam, FRCS (Orth)
Organizational Affiliation
University Hospitals, Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
Please Select
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Optimal Blood Sampling Site for Point of Care Lactate Assessment
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