Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
NCT ID: NCT04113148
Last Updated: 2019-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
170 participants
OBSERVATIONAL
2019-06-01
2020-01-31
Brief Summary
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The investigators would like to see whether non-invasive measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk of it happening.
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Detailed Description
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The aim is to investigate whether non-invasive physiological measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy volunteer
Physiological measurements from heel over 60 minute period
Physiological measurements from heel
Measurements of blood flow, tissue oxygen saturation, temperature, pressure
At risk of Pressure Ulcer
Physiological measurements from heel over 60 minute period
Physiological measurements from heel
Measurements of blood flow, tissue oxygen saturation, temperature, pressure
Confirmed Catefory I Pressure Ulcer
Physiological measurements from heel over 60 minute period
Physiological measurements from heel
Measurements of blood flow, tissue oxygen saturation, temperature, pressure
Suspected Deep Tissue Injury
Physiological measurements from heel over 60 minute period
Physiological measurements from heel
Measurements of blood flow, tissue oxygen saturation, temperature, pressure
Interventions
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Physiological measurements from heel
Measurements of blood flow, tissue oxygen saturation, temperature, pressure
Eligibility Criteria
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Inclusion Criteria
* Able to give consent
* Male or female
* Over the age of 18 years
* No known peripheral vascular disease
* No known tissue damage
* Able to read and understand basic English language
PATIENTS:
* Able to give consent
* Male or female
* Over the age of 18 years
* Either at risk (Braden scale \<17) or confirmed Category 1 or 2 PU or confirmed DTI
* Well enough to attend lab without any attachments (IV fluids, IV medications, oxygen)
* Able to transfer to bed with assistance of one
* Able to read and understand basic English Language
Exclusion Criteria
* Presence of tissue damage or ulceration in the foot
* Known peripheral vascular disease
* Known hypersensitivity to fixation tape
* Presence of a pacemaker
* Participants unable to or refusing to give informed consent
PATIENTS:
* Known hypersensitivity to fixation tape
* Participants unable to or refusing to give informed consent
* Unable to transfer to bed with assistance of one.
* Requiring more than routine observations and requiring attachments (IV fluids, IV medications, oxygen)
* Presence of a pacemaker
18 Years
99 Years
ALL
Yes
Sponsors
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Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Gerard Stansby, MBBS
Role: PRINCIPAL_INVESTIGATOR
Newcastle upon Tyne NHS Hospitals Foundation Trust/Newcastle University
Locations
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Vascular Dept
Newcastle, Tyne and Wear, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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8779
Identifier Type: OTHER
Identifier Source: secondary_id
FO18022
Identifier Type: -
Identifier Source: org_study_id
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