Pressure Area Distribution on a Variety of Clinical Surfaces

NCT ID: NCT03148821

Last Updated: 2023-11-07

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pressure Ulcer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteer participants

The investigators propose a snap shot study in a group of healthy volunteers of varying BMIs, laying on surfaces a patient would be exposed to during their hospital stay. Participants will lie on a variety of surfaces they may find themselves on during an emergency admission to hospital, including an operating table, in a variety of positions. Participants pressure distributions in each scenario will be measured with a pressure sensing mattress.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brighton and Sussex University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, United Kingdom

Site Status

Countries

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United Kingdom

References

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Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086.

Reference Type BACKGROUND
PMID: 15082426 (View on PubMed)

Chen HL, Chen XY, Wu J. The incidence of pressure ulcers in surgical patients of the last 5 years: a systematic review. Wounds. 2012 Sep;24(9):234-41.

Reference Type BACKGROUND
PMID: 25874704 (View on PubMed)

Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care. 2012 Jun;21(6):261-2, 264, 266. doi: 10.12968/jowc.2012.21.6.261.

Reference Type BACKGROUND
PMID: 22886290 (View on PubMed)

DOWNIE F, GUY H, GILROY P, ROYALL D, DAVIES S. Are 95% of hospital-acquired pressure ulcers avoidable?. Wounds UK. 2013 Sep 1;9(3).

Reference Type BACKGROUND

Hibbs P. The economic benefits of a prevention plan for pressure sores. In4th National Pressure Sore Symposium, Bath 1988 Apr (Vol. 20).

Reference Type BACKGROUND

McInnes E, Jammali-Blasi A, Bell-Syer S, Dumville J, Cullum N. Preventing pressure ulcers--Are pressure-redistributing support surfaces effective? A Cochrane systematic review and meta-analysis. Int J Nurs Stud. 2012 Mar;49(3):345-59. doi: 10.1016/j.ijnurstu.2011.10.014. Epub 2011 Nov 20.

Reference Type BACKGROUND
PMID: 22104042 (View on PubMed)

National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Perth, Australia; 2014.

Reference Type BACKGROUND

Other Identifiers

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169214

Identifier Type: -

Identifier Source: org_study_id

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