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Pressure Area Distribution on a Variety of Clinical Surfaces

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ClinicalTrials.gov Identifier: NCT03148821
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
National Institute of Academic Anaesthesia
Information provided by (Responsible Party):
Brighton and Sussex University Hospitals NHS Trust

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.


Condition or disease
Pressure Ulcer

Study Type : Observational
Estimated Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pressure Area Distribution on a Variety of Clinical Surfaces in a Group of 51 Volunteers
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Group/Cohort
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.



Primary Outcome Measures :
  1. PRESSURE AREA DISTRIBUTION ON A VARIETY OF CLINICAL SURFACES IN A GROUP OF 51 VOLUNTEERS [ Time Frame: 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 Outcome Measures :
  1. PRESSURE AREA DISTRIBUTION ON A VARIETY OF CLINICAL SURFACES IN A GROUP OF 51 VOLUNTEERS [ Time Frame: 125 minutes ]
    Gain information to allow calculation of a sample size for a definitive study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants in the study will be adults with full mobility, with the capacity to give informed written consent. We will recruit a group of volunteers in order represent a variety of BMIs, in an attempt to gain a sample of the BMIs found in the population.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148821


Contacts
Contact: Christopher Ranns, MBBS 01273696955 ranns@doctors.org.uk
Contact: Mark Harper, MBBS 07491225814 mark.harper@doctors.org.uk

Locations
United Kingdom
Brighton and Sussex University Hospitals NHS Trust Recruiting
Brighton, East Sussex, United Kingdom, TN62DS
Contact: Mark Harper, MBBS FRCA    0044(0)1273696955 ext 4307    mark.harper@doctors.org.uk   
Principal Investigator: Christopher Ranns, MBBS BSc         
Principal Investigator: Mark Harper, MBBS FRCA         
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
National Institute of Academic Anaesthesia

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

Responsible Party: Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03148821     History of Changes
Other Study ID Numbers: 169214
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The authors plan to disseminate the findings of this study by publishing in the academic literature.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brighton and Sussex University Hospitals NHS Trust:
pressure ulcer
pressure sore
patient positioning

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases