Clinical trial NCT05312333: Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital
Official title: Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill Childern in PICU
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill children are those children whom requiring, or potentially requiring, high reliance or serious consideration.

There are variant emergent conditions may affect the child, such as airway problems which includes tonsillitis, airway obstruction which caused be foreign-body, pneumonia, asthma, and bronchitis, in addition to cardiac arrest and respiratory failure. There is also abdominal pain diarrhea, nausea, and vomiting. Child also may face seizures, poisoning sudden infant death syndrome (SIDS).

* Having seizures; unusual movements.
* No spontaneous development, unfit to sit or stand.
* Less alert or drew in with clinician or parental figure; not resisting of the examination.
* No interaction or eye-to-eye connection with individuals and the surrounding.

Brief summary: Holter Monitoring is a way to continuously check the electrical activity of the heart .

Continuous ECG recording show to be one of the most effective noninvasive clinical tools in the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac therapeutic intervention.

The clinical utility of ambulatory ECG lies in its ability to examine continuously a patient over an extended period of time, permitting patient ambulatory activity and facilitating the diurnal electrocardiographic examination of a patient in a changing environmental conditions (both physical and psychological) .


Eligibility criteria: Inclusion Criteria:

* 1- children admitted to pediatric department as in :
* Pediatric intensive care unit (PICU).
* Pediatric critical care unit (PCCU).
* Emergency room (ER). 2- Age from 1 month- 12 years. 3- Critical ill child fulfill these criteria:
* Persistent convulsions.
* Abnormal GCS
* Haemodynamic instability
* Foreign body inhalation
* Sever cardiac problem
* Irregular breathing
* DKA
* Others

Exclusion Criteria:1-Neonates 2-End-stage or those with end-organ failure . 3-Whom GCS is below 6. 4-Whom done cardiac catheterization for any purpose . 5-Previously done Holter. 6-Multiple traumatized patient.

Primary outcomes:
measure: Abnormalities detecred in Holter monitoring of critically-ill childern
timeFrame: one year
measure: The relation between heart rate variability and outcome ,prognosis of illness
timeFrame: one year
measure: Arrhythmia detected in critically-ill childern
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Kennedy HL. The history, science, and innovation of Holter technology. Ann Noninvasive Electrocardiol. 2006 Jan;11(1):85-94. doi: 10.1111/j.1542-474X.2006.00067.x.
citation: Marsillio LE, Manghi T, Carroll MS, Balmert LC, Wainwright MS. Heart rate variability as a marker of recovery from critical illness in children. PLoS One. 2019 May 17;14(5):e0215930. doi: 10.1371/journal.pone.0215930. eCollection 2019.
citation: Leteurtre S, Duhamel A, Salleron J, Grandbastien B, Lacroix J, Leclerc F; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). PELOD-2: an update of the PEdiatric logistic organ dysfunction score. Crit Care Med. 2013 Jul;41(7):1761-73. doi: 10.1097/CCM.0b013e31828a2bbd.
citation: Rijnbeek PR, Witsenburg M, Schrama E, Hess J, Kors JA. New normal limits for the paediatric electrocardiogram. Eur Heart J. 2001 Apr;22(8):702-11. doi: 10.1053/euhj.2000.2399.