Clinical trial NCT02770638: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Occiput tissue pressure in millimetres mercury (mmHg)
timeFrame: 1 day
Secondary outcomes:
measure: Scapulae tissue pressure in millimetres mercury (mmHg)
timeFrame: 1 day
measure: Sacrum tissue pressure in millimetres mercury (mmHg)
timeFrame: 1 day
measure: Heels tissue pressure in millimetres mercury (mmHg)
timeFrame: 1 day
measure: Subjective participant reported pain levels using visual analogue scale (VAS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Kimberley L Edwards, MMedSci PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.