Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration (OPUS)

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Unknown

Conditions: Pressure Ulcer

Treatments: Other: Physiological measurements from heel

Study type: Observational

Funder types: Other

Identifiers

NCT04113148

FO18022

8779 (Other Identifier)

Details and patient eligibility

About

Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.

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.

Full description

Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

HEALTHY VOLUNTEERS:

• 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

HEALTHY VOLUNTEERS:

• 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

Trial design

170 participants in 4 patient groups

Healthy volunteer

Description:

Physiological measurements from heel over 60 minute period

Treatment:

Other: Physiological measurements from heel

At risk of Pressure Ulcer

Description:

Physiological measurements from heel over 60 minute period

Treatment:

Other: Physiological measurements from heel

Confirmed Catefory I Pressure Ulcer

Description:

Physiological measurements from heel over 60 minute period

Treatment:

Other: Physiological measurements from heel

Suspected Deep Tissue Injury

Description:

Physiological measurements from heel over 60 minute period

Treatment:

Other: Physiological measurements from heel