Clinical trial NCT04066686: Evaluation of Comfort in a Spinal Collar
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Injuries
Keywords: Neck Injuries
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 18yrs and over who are admitted to St Mary's Hospital with a C-spine injury will be invited to participate

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. All patients aged 18yrs and over with a C-spine injury immobilised in a spinal collar
2. Patients must be nursed on Major Trauma Ward
3. Ability to give informed consent to participate in the study.

Exclusion Criteria:

1. Patients under 18yrs age
2. Patients who lack capacity to consent for entry into the study
3. Patients who are receiving level 2( High dependency unit) or level 3 (Intensive care unit) clinical care
4. 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.
5. Patients unable to understand the patient leaflet in English.

Primary outcomes:
measure: Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury.
timeFrame: During inpatient admission (an average of two weeks)
Secondary outcomes:
measure: Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury.
timeFrame: At baseline (retrospectively) and at time of wearing the spinal collar after injury
measure: Measurement of Spinal Angulation
timeFrame: Through study completion, up to one year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Heathcare NHS Trust
Study officials:
affiliation: Study Principal Investigator Imperial College Healthcare NHS Trust
name: Michael Fertleman
role: PRINCIPAL_INVESTIGATOR
References: