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Tissue Interface Pressures in Athlete Medical Extraction

Primary Purpose

Emergency, Pain, Medical Device Discomfort

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Scoop Stretcher
Long Back Spinal board
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergency focused on measuring Healthy, Sport, Athlete, Male, University, Adults, Rugby Football Union, Professional, Competitive sport, Scoop Stretcher, Ferno Scoop Stretcher, Long back spinal board, Emergency Medical Services, Long backboard, Patient Extrication, Triple Immobilisation, Pre hospital Medicine, Rigid Cervical Collar, Pressure Testing, Tissue Pressure Testing, Visual Analogue Scale, Pressure Sores, Pressure area damage, Tissue Viability, Tissue Interface Pressure, Comfort, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy, uninjured - no current sports injury, male, 75kg (165 lb) in weight or over.

Exclusion Criteria:

  • Female, weight less than 75kg (165 lb)

Sites / Locations

  • University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scoop Stretcher

Long Back Spinal Board

Arm Description

Participant wearing light sports clothing will start with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps).

Participant wearing light sports clothing will start with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps).

Outcomes

Primary Outcome Measures

Occiput tissue pressure in millimetres mercury (mmHg)

Secondary Outcome Measures

Scapulae tissue pressure in millimetres mercury (mmHg)
Sacrum tissue pressure in millimetres mercury (mmHg)
Heels tissue pressure in millimetres mercury (mmHg)
Subjective participant reported pain levels using visual analogue scale (VAS)

Full Information

First Posted
May 9, 2016
Last Updated
July 7, 2022
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT02770638
Brief Title
Tissue Interface Pressures in Athlete Medical Extraction
Official Title
A Comparison of Tissue Interface Pressures and Comfort Ratings of the Scoop Stretcher and Traditional Long Back Board in Rugby and University Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to establish clinical evidence for the use of scoop stretchers in the sports setting for spinal immobilisation and transport compared to the traditionally used long back boards through measuring tissue interface pressures over forty five minutes. All participants will be placed on both the scoop stretcher and the long back board for forty five minutes each, with at least 45 minutes between the two tests. A special mat that measures the pressure of the body against the board will be used to determine the pressure forces at certain points of the body touching the board (in mmHg). The participants will also be asked every five minutes during the experiment to rate the comfort of the device. Pressure measures from each participant on each board will be collated and assessed along with each participant's reported pain scores and comfort rating. The measurements from the tissue pressures will be analysed in real-time from the software connected to the pressure-mat and therefore show if pressures increase over time. A comparison between boards will be made.
Detailed Description
Background In recent years the scoop stretcher, for a number of reasons, has been advocated by the Faculty for Pre-hospital Care (Royal College of Surgeons Edinburgh, United Kingdom) as the 'Gold Standard' method of extrication and transport in pre-hospital trauma and this has been extrapolated to extricating athletes from the field of play in sport who have sustained a potential spine injury. In addition they have advised that the conventional long back boards should no longer to be used as a stretcher, only a pure extrication device. This has an implication to the emergency care currently provided in sport and will affect every sports club financially and every medical team who require training in the use of the new device. Previous research studies have looked at how much pressure lying on different spinal boards (e.g. the long back board or vacuum mattress) causes the athlete. This is because of a concern that lying on a board for too long may cause pressure sores or other medical complications. However, no research has been done to measure these tissue pressures using the scoop stretcher which is now indicated for general use in pre-hospital care in sport. Also there is no evidence to compare how comfortable athletes find the different spinal boards. Aims This observational study aims to measure the tissue interface pressures and perceived levels of comfort of rugby players and University participants (staff and students) immobilised on a scoop stretcher and on a long back board for forty five minutes. It will also enable the changes in pressures and comfort ratings over time to be assessed to evaluate the appropriate time cut off for such immobilisation. Experimental Protocol and Methods A prospective cross-over study. Players from Nottingham Rugby Football Club and the University of Nottingham (staff and students) will be invited to participate for the study (summer 2016). Participants will be randomly (block randomisation) assigned to start on either the scoop or long board. Participants will be log rolled onto each board and fully immobilised for forty five minutes. The wash out period will be a minimum of forty five minutes. All measurements will be collected on the same pressure mat. Measureable end points/statistical power of the study The pressure mat (provided by BES Rehab) will be laid on top of the spinal board and will automatically measure the tissue interface pressure readings (occiput, scapulae, sacrum, heels) every five minutes. Participant reported pain will be measured by a Visual Analogue Scale (VAS) and will be used to collect the comfort ratings data (occiput, scapulae, sacrum, heels, overall) every five minutes. Age, height, weight, sport team and position played and length of sporting participation will also be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency, Pain, Medical Device Discomfort
Keywords
Healthy, Sport, Athlete, Male, University, Adults, Rugby Football Union, Professional, Competitive sport, Scoop Stretcher, Ferno Scoop Stretcher, Long back spinal board, Emergency Medical Services, Long backboard, Patient Extrication, Triple Immobilisation, Pre hospital Medicine, Rigid Cervical Collar, Pressure Testing, Tissue Pressure Testing, Visual Analogue Scale, Pressure Sores, Pressure area damage, Tissue Viability, Tissue Interface Pressure, Comfort, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scoop Stretcher
Arm Type
Experimental
Arm Description
Participant wearing light sports clothing will start with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps).
Arm Title
Long Back Spinal Board
Arm Type
Active Comparator
Arm Description
Participant wearing light sports clothing will start with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps).
Intervention Type
Device
Intervention Name(s)
Scoop Stretcher
Other Intervention Name(s)
Trade Name: Ferno Scoop Stretcher
Intervention Description
Participants recruited by community advertisement. Participant will complete forty five minutes on scoop stretcher first, followed by forty five minute washout period, finished with forty five minutes on the long back spinal board. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals.
Intervention Type
Device
Intervention Name(s)
Long Back Spinal board
Intervention Description
Participants recruited by community advertisement. Participant will complete forty five minutes on the long back spinal board first, followed by forty five minute washout period, finished with forty five minutes on the scoop stretcher. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals.
Primary Outcome Measure Information:
Title
Occiput tissue pressure in millimetres mercury (mmHg)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Scapulae tissue pressure in millimetres mercury (mmHg)
Time Frame
1 day
Title
Sacrum tissue pressure in millimetres mercury (mmHg)
Time Frame
1 day
Title
Heels tissue pressure in millimetres mercury (mmHg)
Time Frame
1 day
Title
Subjective participant reported pain levels using visual analogue scale (VAS)
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, uninjured - no current sports injury, male, 75kg (165 lb) in weight or over. Exclusion Criteria: Female, weight less than 75kg (165 lb)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberley L Edwards, MMedSci PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG72UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23080314
Citation
Hanson JR, Carlin B. Sports prehospital-immediate care and spinal injury: not a car crash in sight. Br J Sports Med. 2012 Dec;46(16):1097-101. doi: 10.1136/bjsports-2012-091800. Epub 2012 Oct 18.
Results Reference
background
PubMed Identifier
16418091
Citation
Krell JM, McCoy MS, Sparto PJ, Fisher GL, Stoy WA, Hostler DP. Comparison of the Ferno Scoop Stretcher with the long backboard for spinal immobilization. Prehosp Emerg Care. 2006 Jan-Mar;10(1):46-51. doi: 10.1080/10903120500366375.
Results Reference
background
PubMed Identifier
24232010
Citation
Moss R, Porter K, Greaves I; consensus group. Minimal patient handling: a faculty of prehospital care consensus statement. Emerg Med J. 2013 Dec;30(12):1065-6. doi: 10.1136/emermed-2013-203205.
Results Reference
background

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Tissue Interface Pressures in Athlete Medical Extraction

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