Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital

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) .

Study Overview

• Status: Recruiting
• Conditions: Critically Ill Childern in PICU

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Osama R ElSherif, professor; Email: portal@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
critically-ill childern

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormalities detecred in Holter monitoring of critically-ill childern	the relation between abnormalities detected in Holter and prognosis of critically-ill childern	one year
The relation between heart rate variability and outcome ,prognosis of illness	Increased illness severity and poor outcomes ,the most common method of objectively assesing autonomic nervous system dysregulation is through measurement of heart rate variability ,which reflect the normal ,physiologic alternation in the intervals in the time between consecutive heart beats that occur when there is balance of sympathetic and parasympathetic inputs on the electrical conduction system of the heart.	one year
Arrhythmia detected in critically-ill childern	arrhythmia detected in Holter of critically ill childern whom have any critical illness	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 13, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Soh-Med-22-03-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No