- ICH GCP
- US Clinical Trials Registry
- 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 (Pre-HAST)
A Validation Study of a Structured Diagnostic Examination of Patients With Suspected or Confirmed Stroke Resulting in a Stroke Score
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PreHAST (PreHospital Ambulance Stroke Test)
for suspected stroke in awake patients The following parameters are tested.
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
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
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
- Facial palsy Ask the patient to smile 0 - normal 1 - one side of the mouth is hanging
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
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
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
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden
- Södersjukhuset
-
-
Skåne
-
Hässleholm, Skåne, Sweden
- Pre hospital services in Skåne, Sweden
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suspected stroke
Exclusion Criteria:
- Unconscious
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suspected stroke
Patients with suspected stroke who are evaluated by paramedics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stroke diagnosis
Time Frame: within 2 weeks of recrutiment
|
The Pre-HAST is performed in the ambulance, in the emergency room or in the acute stroke ward.
Final diagnosis of stroke and imaging data is matched to the findings in the Pre-HAST test
|
within 2 weeks of recrutiment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neuroimaging findings of large vessel oclusion
Time Frame: within 3 months
|
Imaging findings of examined patients are reviewed
|
within 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pre-HAST
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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