Pressure Area Distribution on a Variety of Clinical Surfaces

Pressure Area Distribution on a Variety of Clinical Surfaces in a Group of 51 Volunteers

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03148821

Enrollment

Registered

2017-05-11

Start date

2017-07-01

Completion date

2018-10-31

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

pressure ulcer, pressure sore, patient positioning

Brief summary

Participants in the study will be adults with full mobility, with the capacity to give informed written consent. The investigators will recruit a group of volunteers in order to represent a variety of BMIs, in an attempt to gain a sample of the BMIs found in the population. The investigators will mimic current practices and standard equipment in order to replicate real conditions as closely as possible. Participants will lay on the following surfaces in the following scenarios 1. Ambulance scoop: supine (lying flat on their back) 2. A&E trolley: supine 3. Hospital bed: supine 4. Theatre table: supine 5. Theatre table: Left lateral (lying on their left side at 90 degrees to the operating table) with pelvic binders (pads designed to keep the hip immobile). Each participant will remain in each position on that particular surface for a period of 25 minutes. A pressure mapping mattress will lie between the participant and the surface assessed to generate a pressure map. Following completion of data collection, data will be analysed and any areas of potential pressure damage vulnerability will be identified.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

• Subjects will be individuals aged 18 and over, with good command of spoken and written English, full mobility, and the capacity to give informed, written consent. Provided there is no impairment to mobility, there is no upper age limit to participation.

Exclusion criteria

* Inability to provide informed written consent * Having a BMI that falls outside of the stated ranges for the study (\<19) * Any significant impairment to mobility, for whatever reason, that prevents the patient from getting in and out of bed unaided, walking 100 metres unaided, or climbing a flight of stairs unaided. * Patients who lack sufficient command of written and spoken English to allow them to give written informed consent take part.

Design outcomes

Primary

Measure	Time frame	Description
PRESSURE AREA DISTRIBUTION ON A VARIETY OF CLINICAL SURFACES IN A GROUP OF 51 VOLUNTEERS	125 minutes	Establish the pressure distributions of current patient surfaces in use, for a variety of different sized patients, to identify any points in the patient's journey when they are at risk of developing pressure damage.

Secondary

Measure	Time frame	Description
PRESSURE AREA DISTRIBUTION ON A VARIETY OF CLINICAL SURFACES IN A GROUP OF 51 VOLUNTEERS	125 minutes	Gain information to allow calculation of a sample size for a definitive study.

Countries

United Kingdom

Outcome results