CClinicalTrials.gg
Status unknownNCT04575376Updated Feb 21, 2021

Clinical Audit on Evaluation of Patient With Syncope at Asssiut University Children Hospital

An observational study in Syncope, sponsored by Assiut University. Status unknown. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
30
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the detailed 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)
02

Conditions studied

  • Syncope

Browse trials for

03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's planned enrollment of 30 is below the median of 221 across 91 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with syncope who will be admitted to Assiut University Children Hospital.

Inclusion criteria

  • all cases of syncope.

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. No abstract available. PubMed 25980576 ↗
  • Johnsrude CL. Current approach to pediatric syncope. Pediatr Cardiol. 2000 Nov-Dec;21(6):522-31. doi: 10.1007/s002460010130. PubMed 11050276 ↗
  • 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. PubMed 26732063 ↗
  • 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. PubMed 25802162 ↗
  • Yilmaz S, Gokben S, Levent E, Serdaroglu G, Ozyurek 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. PubMed 22459868 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04575376
Lead sponsor
Assiut University
Responsible party
MENazeer (Doctor, Assiut University) — Principal investigator
First posted
Oct 5, 2020
Start date
Apr 2021 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
Feb 21, 2021

Study contacts

Merna Ezzat
Contact
mernaezzat852456@gmail.com
01223554098
Zeinab Mohie El-deen, Professor
Contact
Zainab.mohamed@med.au.edu.eg
01149913112
Zeinab Mohie El-deen, Professor
study director · Asssiut University
faisal al_khateeb ahmed, Professor
study director · Asssiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion