Evaluation of Comfort in a Spinal Collar
1. juli 2021 opdateret af: Imperial College Healthcare NHS Trust
Evaluation on the Level of Discomfort and Restriction on Activities of Daily Living (ADLs) Whilst C-spine Immobilised in a Spinal Collar After C-spine Injury.
This is an observational study which aims to assess the comfort of a spinal collar in patients who have them fitted as part of their clinical care due to neck injury.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The study follows the patient journey including long term follow up (up to 120 days following admission).
The information gathered will be from the standard clinical care delivered and include demographics, baseline function, the injuries sustained following trauma and prescribed analgesia with records of the most recent time and dose administered.
Any scans done of the neck for clinical purposes will be anonymised and analysed for measurements of angulation.
In addition to this there will be a survey on the comfort of the collar and of their functional ability at the current time at various points during their inpatient admission.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
27
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige
- Imperial College Heathcare NHS Trust
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All patients aged 18yrs and over who are admitted to St Mary's Hospital with a C-spine injury will be invited to participate
Beskrivelse
Inclusion Criteria:
- All patients aged 18yrs and over with a C-spine injury immobilised in a spinal collar
- Patients must be nursed on Major Trauma Ward
- Ability to give informed consent to participate in the study.
Exclusion Criteria:
- Patients under 18yrs age
- Patients who lack capacity to consent for entry into the study
- Patients who are receiving level 2( High dependency unit) or level 3 (Intensive care unit) clinical care
- Patients who are unable to complete the visual analogue score or questionnaire due to having co-existent severe hearing and visual impairment. Severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. Severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids.
- Patients unable to understand the patient leaflet in English.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Young
Participants recruited into one of two groups on age stratification.
Young cohort defined as aged 18-65yrs old
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Elderly
Participants recruited into one of two groups on age stratification.
Elderly cohort defined as over 65yrs of age.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury.
Tidsramme: During inpatient admission (an average of two weeks)
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'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)
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During inpatient admission (an average of two weeks)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury.
Tidsramme: At baseline (retrospectively) and at time of wearing the spinal collar after injury
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'Neck Disability Index' Questionnaire (Validated functional assessment which consists of ten questions to assess how that persons neck pain affects abilities in everyday life.
It is a questionnaire format with multi-choice answer options).
Minimum score = 0, Maximum score = 50.
The overall percentage score is calculated as follows: e.g.
16 (total scored) divided by 50 (total possible score) x 100 = 32%.
A higher percentage indicates a worse outcome i.e. higher disability.
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At baseline (retrospectively) and at time of wearing the spinal collar after injury
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Measurement of Spinal Angulation
Tidsramme: Through study completion, up to one year
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Measurements of angulation between specified bony anatomical landmarks to investigate degree of curvature within the C-spine performed on any neck imaging completed as part of routine clinical care.
Statistical analysis to allow comparison of young and elderly groups.
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Through study completion, up to one year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Michael Fertleman, Study Principal Investigator Imperial College Healthcare NHS Trust
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. oktober 2018
Primær færdiggørelse (Faktiske)
29. maj 2019
Studieafslutning (Faktiske)
29. maj 2019
Datoer for studieregistrering
Først indsendt
19. august 2019
Først indsendt, der opfyldte QC-kriterier
21. august 2019
Først opslået (Faktiske)
26. august 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18SM4650
Plan for individuelle deltagerdata (IPD)
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