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Orthostatic related blood pressure changes in syncope patients in the emergency department

Completed
Conditions
Syncope
fainting
loss of consciusness
10011954
Registration Number
NL-OMON42478
Lead Sponsor
Acute interne geneeskunde
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

• The patient must be 18 years or older.
• The reason for referral to the emergency department must be (pre-) syncope.
• The patient must be able to stand for 5 minutes with little assistance.

Exclusion Criteria

• The patient is not able to stand for 5 minutes (with little assistance)
• The patient is hemodynamically instable (with supine resting SBP <90 mmHg or DBP <50 mmHg)
• The patient needs immediate additional investigations/treatment
• The patient is psychologically, physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator
• The patient has a MMSE score <21 during the first outpatient clinic visit
• The patient is geographically or otherwise inaccessible to follow up
• The patient is unwilling or unable to give informed consent
• The patient has atrial fibrillation in the emergency department
• When there are other reasons for transient loss of consciousness, which do not fit the definition of syncope, such as alcohol, illicit drugs, seizure, stroke/transient ischemic attack, head trauma or hypoglycemia
• Life expectancy < 1 year
• If Nexfin measurement is not possible, for example due to deformation of the fingers, Raynaud's phenomenon or peripheral vasoconstriction

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter at the initial evaluation in the ED is the difference<br /><br>between the proportion of correct working diagnosis made by the attending<br /><br>physician and by the investigator.<br /><br><br /><br>For the follow-up at the outpatient department the main study parameter is the<br /><br>difference in (pre-) syncope recurrence during the 1 year follow-up in<br /><br>comparison with the previous year. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary study parameters for the initial evaluation in the ED is:<br /><br>• The difference between the proportion of correct working diagnosis in the<br /><br>patients of group 1, before and after the evaluation with Nexfin<br /><br><br /><br>The secondary study parameters for the follow-up at the outpatient department<br /><br>are:<br /><br>• Quality of life after one year of follow-up<br /><br>• Falls history of the past year in comparison with the follow-up year in<br /><br>patients of 60 years and older<br /><br>• The recovery to normalisation of the orthostatic blood pressure recovery<br /><br>patterns<br /><br>• 30 days mortality, one year mortality<br /><br><br /><br>For all secondary study parameters from the follow-up there will be a sub<br /><br>analysis between the group with Nexfin measurement and the blinded Nexfin<br /><br>measurement. </p><br>
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