A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital

NCT ID: NCT05322772

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-04-30

Brief Summary

Convulsion is a common pediatric disorder and there is strong relation between convulsion and cardiovascular system which revealed by ECG monitoring and there are many ECG abnormalities attributed to different causes of convulsions, A 12-lead ECG is a low-cost test and can detect clinically significant abnormalities such as long QTc interval or heart block. Doing an ECG in all patients presenting with seizures clinic, inevitably, pick up non-specific abnormalities which require further investigation. Moreover, a normal 12-lead ECG does not exclude a cardiovascular cause for collapse and for those in whom a cardiac cause is still suspected despite a normal ECG, referral to a cardiologist is advisable

Conditions

Convulsions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

children with epilepsy

epilepsy diagnosed clinically EEG

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

children with febrile convulsions

the child has high grade fever from 6 month to 6 years not recurrent duration less than 15 minute or atypical febrile convulsions

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

children with cns infection

the child has fever, neck, rigidity DCL

+or- CSF analysis

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

children with electrolyte imbalance, hypoglycemia

abnormal values of electrolyte hypoglycemia

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

children with poisoning

history of ingestion or inhalation of toxic substance

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

children with encephalopathy

the child complains of brain disease or mal function with altered mental status as a complication of primary illness as kidney failure ,cirrhosis, etc.

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

children with trauma

history of trauma imaging study done

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

children with genetic cause

the child has congenital anomaly as chromosomal abnormality, metabolic disease, mitochondrial disease

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

others

children not fulfilling the previous groups

ECG

Intervention Type: DEVICE

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

Interventions

ECG

ii. 12 leads ECG: 12 leads ECG will be done to all infants \& children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.

Exclusion Criteria

• Children not filling the criteria of convulsions (like conditions mimic epilepsy)
• Children with known cardiac disease or cardiac arrhythmia and patients who will not give consent will be excluded.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Eman Aiman Sadek

resident doctor at pediateric department sohag general hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eman A Sadek

Role: CONTACT

eman011064@med.sohag.edu.eg

01156556464 ext. 002

Montaser M Mohamed

Role: CONTACT

montaser-dabah@yahoo.com

01026372799 ext. 002

References

Huang X, Malek N, Simpson J, Kalladka D, Dunn FG, Leach JP. Winning hearts and minds: ECG reporting in the first seizure clinic. BMC Cardiovasc Disord. 2021 Jul 31;21(1):364. doi: 10.1186/s12872-021-02174-4.

Reference Type: BACKGROUND

PMID: 34332536 (View on PubMed)

Rijnbeek PR, Witsenburg M, Szatmari A, Hess J, Kors JA. PEDMEANS: a computer program for the interpretation of pediatric electrocardiograms. J Electrocardiol. 2001;34 Suppl:85-91. doi: 10.1054/jelc.2001.28835.

Reference Type: BACKGROUND

PMID: 11781941 (View on PubMed)

Karjalainen J, Viitasalo M. Fever and cardiac rhythm. Arch Intern Med. 1986 Jun;146(6):1169-71.

Reference Type: BACKGROUND

PMID: 2424378 (View on PubMed)

Other Identifiers

Soh-Med-22-03-05

Identifier Type: -

Identifier Source: org_study_id