N/A
N=27
Evaluation of Comfort in a Spinal Collar
Neck Injuries
Bottom Line
View on ClinicalTrials.gov: NCT04066686 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury. — 1; 4.9 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury. |
1; 4.9 | — |
| SECONDARY Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury. |
8.99; 6.28; 50.83; 35.67 | — |
| SECONDARY Measurement of Spinal Angulation |
— | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04066686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.