Tissue Interface Pressures in Athlete Medical Extraction

NCT02770638 | Completed

• 1 other identifier: G10042014 SoM ROD
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Occiput tissue pressure in millimetres mercury (mmHg)

  1 day

Secondary Outcomes (4)

• Scapulae tissue pressure in millimetres mercury (mmHg)

  1 day

• Sacrum tissue pressure in millimetres mercury (mmHg)

  1 day

• Heels tissue pressure in millimetres mercury (mmHg)

  1 day

• Subjective participant reported pain levels using visual analogue scale (VAS)

  1 day

Study Arms (2)

Scoop Stretcher

EXPERIMENTAL

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).

Device: Scoop Stretcher

Long Back Spinal Board

ACTIVE COMPARATOR

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).

Device: Long Back Spinal board

Interventions

Scoop Stretcher DEVICE

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.

Also known as: Trade Name: Ferno Scoop Stretcher

Scoop Stretcher

Long Back Spinal board DEVICE

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.

Long Back Spinal Board

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG72UH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 23080314 BACKGROUND

• 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.

  PMID: 16418091 BACKGROUND

• 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.

  PMID: 24232010 BACKGROUND

MeSH Terms

Conditions

Emergencies; Pain; Pressure Ulcer

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kimberley L Edwards, MMedSci PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sport Exercise & Nutrition Education

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 12, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)