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
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
- Ambulance scoop: supine (lying flat on their back)
- A&E trolley: supine
- Hospital bed: supine
- Theatre table: supine
- 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|
|Study Type :||Observational|
|Estimated Enrollment :||51 participants|
|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|
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.
- 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.
- 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.
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
|Contact: Christopher Ranns, MBBSfirstname.lastname@example.org|
|Contact: Mark Harper, MBBSemail@example.com|
|Brighton and Sussex University Hospitals NHS Trust||Recruiting|
|Brighton, East Sussex, United Kingdom, TN62DS|
|Contact: Mark Harper, MBBS FRCA 0044(0)1273696955 ext 4307 firstname.lastname@example.org|
|Principal Investigator: Christopher Ranns, MBBS BSc|
|Principal Investigator: Mark Harper, MBBS FRCA|