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

• Sponsor: Sohag University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05312333
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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) .

Condition or Disease	Intervention/Treatment	Phase
Critically Ill Childern in PICU

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Official Title: Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital
• Actual Study Start Date: Mar 9, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
critically-ill childern

Outcome Measures

Primary Outcome Measures

1. Abnormalities detecred in Holter monitoring of critically-ill childern [one year]

   the relation between abnormalities detected in Holter and prognosis of critically-ill childern

2. The relation between heart rate variability and outcome ,prognosis of illness [one year]

   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.

3. Arrhythmia detected in critically-ill childern [one year]

   arrhythmia detected in Holter of critically ill childern whom have any critical illness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University Hospital	Sohag		Egypt

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kennedy HL. The history, science, and innovation of Holter technology. Ann Noninvasive Electrocardiol. 2006 Jan;11(1):85-94.
• Leteurtre S, Duhamel A, Salleron J, Grandbastien B, Lacroix J, Leclerc F; Groupe Francophone de Réanimation et d'Urgences Pédiatriques (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.
• 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.

• Responsible Party: Nourhan Ahmed Mohamed, resident doctor at pediateric department sohag university hospital, Sohag University
• ClinicalTrials.gov Identifier: NCT05312333
• Other Study ID Numbers: Soh-Med-22-03-12
• First Posted: Apr 5, 2022
• Last Update Posted: Apr 5, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Apr 5, 2022