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

February 18, 2021 updated by: MENazeer, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

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)

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • all cases of syncope.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical audit on evaluation of a child with syncope at Assiut University children Hospital
Time Frame: Baseline
Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at Assiut University Children Hospital
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Zeinab Mohie El-deen, Professor, Asssiut University
  • Study Director: faisal al_khateeb ahmed, Professor, Asssiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (ACTUAL)

October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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