Clinical trial NCT04555499: A Diagnosis Study of a New Prehospital Strokeidentification Test, the PreHospitalt Ambulans Stroke Test (PreHAST), to be Used to Triage Patients With Suspected Stroke
Official title: A Validation Study of a Structured Diagnostic Examination of Patients With Suspected or Confirmed Stroke Resulting in a Stroke Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke pre hospital identification TIA
Patients with suspected stroke
Ability to give informed consent
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2020-09-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected stroke using pre hospital services in region Skåne, Sweden or being admited to Södersjukhuset in Stockholm, Sweden

Brief summary: The aim of the Pre-HAST study is to improve identification and triage of patients with suspected stroke in order to get the right patient to the right level of care as fast as possible. Furthermore, the scale is also intended to use follow stroke symptoms in emergency care. The test is more extensive then the FAST or Cincinatti Stroke Scale and is in some aspects similar to the NIHSS but is shorter, easier and faster to perform to improve interexaminator variability and improve validity in less trained personal. The test is intended for awake patients with suspected stroke

Detailed description: PreHAST (PreHospital Ambulance Stroke Test)

* for suspected stroke in awake patients The following parameters are tested.

  1. Commands • Evaluates ability to understand verbal commands (impressive aphasia?) and to carry out complex commands (apraxia?)

     • Give the command: open and close your eyes! Grip your hand! (non-paretic side) 0 - two correct 2 - one or none correct
  2. Eye position • Evaluates involuntary deviation of the gaze (déviation conjugée?). If present, this implies a serious injury and thus 2 p are given.

     • Observ if the patient have the eyes trained to one direction unmotivated 0 - normal 2 - Patient gaze in one direction only or preferably
  3. Visual field

     * The test should be conducte in both left and right visual field simulatneously to evaluate both if hemianopsia and/or negelct are present. Both symptoms implieas a sever injury and thus 2 p are given
     * Look the patient in the eyes and wave in both visual fields simultaneously. Ask the patient to point at the hand or hands waving.

       0 - normal 2 - Only distinguishes one hand
  4. Facial palsy Ask the patient to smile 0 - normal 1 - one side of the mouth is hanging
  5. Arm paresis Is tested in lying or sitting position, one arm at the time. Start with the strongest arm. Lift the arm 45 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the arm, assist.

     If the inability to keep the arm elevated is due to pain - score 0 Right Left 0 - can maintain the arm in postition for 10 s 1 - The arm drifts down from the initial position within 10 s but does not rely on support 2 - Falls down to support within 10 s or directly
  6. Leg paresis Test in lying or sitting position, one leg at the time. Start with the strongest leg. Lift the leg 30 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the leg, assist.

     If the inability to keep the leg elevated is due to pain - score 0 Right Left 0 - can maintain the leg in position for 5 s 1 - The leg drifts down from the initial position within 5 s but does not rely on support 2 - Falls down to support within 5 s or directly
  7. Sensory (pain)

     * Evaluation of eventual loss of sensory function. It is important that pain is tested as not to miss a serious and not too uncommon type of stroke localized in the brain stem (Wallenberg´s syndrome).
     * Pinch the bend of the arms and legs, respectively. The stimuli shall be done simultaneously at the left and right side. Ask the patient if he/she can feel the stimuli in the same way on both sides. If the patient only registers stimuli on one side, 2 p are given.

       0 - normal

       1 - registers stimuli on both sides but less on one side 2 - Only registers the stimuli on one side
  8. Language • Evaluate if the patient has an understandable speech as stroke can cause both slurred speech (dysarthria) and affected ability to find words (aphasia). This test does not distinguish between dysarthria or dysphasia . Patient who does not speak at all (is mute) is given 2 p.

     * Ability to talk is noted during the examination. If uncertain, ask the patient to repeat: "the weather is pretty today" 0 - Normal 1 -Slight or moderate dysartria or aphasia. Communication possible. 2 - Severe dysarthria or aphasia. Communication basically not possible.

Eligibility criteria: Inclusion Criteria:

* Suspected stroke

Exclusion Criteria:

* Unconscious

Primary outcomes:
measure: stroke diagnosis
timeFrame: within 2 weeks of recrutiment
Secondary outcomes:
measure: neuroimaging findings of large vessel oclusion
timeFrame: within 3 months
Other outcomes:
Locations:
city: Hässleholm
country: Sweden
facility: Pre hospital services in Skåne, Sweden
state: Skåne
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
References:
citation: Andsberg G, Esbjornsson M, Olofsson A, Lindgren A, Norrving B, von Euler M. PreHospital Ambulance Stroke Test - pilot study of a novel stroke test. Scand J Trauma Resusc Emerg Med. 2017 Apr 11;25(1):37. doi: 10.1186/s13049-017-0377-x.