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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04575376
Other study ID # Syncope
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date October 2023

Study information

Verified date February 2021
Source Assiut University
Contact Merna Ezzat
Phone 01223554098
Email mernaezzat852456@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at Assiut University Children Hospital and correction of the defect that will be discovered.


Description:

Definition Syncope is a transient loss of consciousness associated with inability to maintain postural tone followed by rapid and spontaneous recovery. (1) Epidemiology About 30-50% of children have syncope at least once in their lives till adolescent period, most of them are girls, 9% is the rate of syncope in 15-17 years old adolescent group, and this rate increase to the end of adolescent period. (2) Causes (3) I_Neurally mediated syncope 1. Neurocardiogenic (vasovagal) - Emotional stress induced (pain, fear, blood phobia, etc.) - Orthostatic stress induced 2. Situational syncope - Respiratory (cough, sneeze, laugh, head turning) - Gastrointestinal stimulation (swallowing, defecation, postprandial) - Post micturition - Post exercise - Others 3. Carotid sinus syncope 4. Glossopharyngeal and trigeminal neuralgia syncope II_Cardiogenic syncope - Arrhythmias as Bradycardia: - sinus node dysfunction (including bradycardia/tachycardia syndrome) - atrioventricular conduction system disease Tachycardia: - supraventricular - ventricular - Structural heart defects as acute myocardial infarction/ischaemia, hypertrophic cardiomyopathy, cardiac masses (atrial myxoma, tumours, etc.), pericardial disease /tamponade. - Functional heart defects as prosthetic valve dysfunction, pulmonary hypertension. - Vascular heart abnormalities as aortic stenosis, congenital anomalies of coronary arteries, pulmonary embolus, acute aortic dissection. III_ Orthostatic hypotensive syncope - Primary autonomic disorder - Secondary autonomic disorder - Drug-induced orthostatic hypotension - Hypovolemia related IV_Postural orthostatic tachycardia syndrome V_Metabolic reasons of syncope - Hypoglycemia - Hypoxia - Electrolyte imbalance VI_Psychogenic syncope - Anxiety - Panic attack - Depression - Somatization VII_Drug-induced syncope - Antihypertensives, diuretics, barbiturates, tricyclic antidepressants, alcohol, antiarrhythmics, macrolides, antihistamines, antipsychotics, MAO inhibitors, levodopa, prazosin, benzodiazepines VIII_Airway obstruction induced syncope IX_Hyperventilation-induced syncope X_Neurologic Syncope - Cerebrovascular diseases - Increased intracranial pressure - Migraine Symptoms - The prodrome is the most important aspect of the history. - A warm or clammy sensation, nausea, light headedness or visual changes (e.g seeing spots, grey out, tunneling)are strongly suggestive of vasovagal syndrome, other symptoms include irritability, confusion, auditory changes or dyspnea. - The absence of prodrome raise the suspicion of a possible cardiac cause. 85%of children with vasovagal syncope has a prodrome, wheras only 40% of those with cardiac condition had a prodromal symptoms. Palpitation and chest pain have been related to pediatric cardiac cause of syncope.(4) vasovagal syncope might also produce complex movement which raise a suspicion of epilepsy.(5) - Most syncope is vasovagal, which is benign and doesn't require extensive investigation. The position statement presents recommendation to encourage an efficient and cost effective deposition for the many patients with a benign cause of syncope and hightlight atypical or concerning clinical findings associated with other causes of transient loss of consciousness. - The prodrome and cirumstances around which the event occurred are the most important aspect of the history. - Syncope occurring midexertion suggest cardiac etiology. A family history includes sudden death in the young or from unknown causes or causes that might be suspected to be other than natural can be a red flag. - ECG is the most frequently ordered test, but the yield is low, It's recommended when patient's history isn't suggestive of vasovagal syncope and other features suggestive of cardiac cause like absence of prodrome, midexertion and family history of early life sudden death or heart diseases, abnormal physical examination or a new medication with potential cardiac cardiotoxicity.(6)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria: - all cases of syncope. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Bayram AK, Pamukcu O, Per H. Current approaches to the clinical assessment of syncope in pediatric population. Childs Nerv Syst. 2016 Mar;32(3):427-36. doi: 10.1007/s00381-015-2988-8. Epub 2016 Jan 5. Review. — View Citation

Hurst D, Hirsh DA, Oster ME, Ehrlich A, Campbell R, Mahle WT, Mallory M, Phelps H. Syncope in the Pediatric Emergency Department - Can We Predict Cardiac Disease Based on History Alone? J Emerg Med. 2015 Jul;49(1):1-7. doi: 10.1016/j.jemermed.2014.12.068. Epub 2015 Mar 20. — View Citation

Johnsrude CL. Current approach to pediatric syncope. Pediatr Cardiol. 2000 Nov-Dec;21(6):522-31. Review. — View Citation

Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. — View Citation

Yilmaz S, Gökben S, Levent E, Serdaroglu G, Özyürek R. Syncope or seizure? The diagnostic value of synchronous tilt testing and video-EEG monitoring in children with transient loss of consciousness. Epilepsy Behav. 2012 May;24(1):93-6. doi: 10.1016/j.yebeh.2012.02.006. Epub 2012 Mar 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical audit on evaluation of a child with syncope at Assiut University children Hospital Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at Assiut University Children Hospital Baseline
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