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

Primary Purpose

Critically Ill Childern in PICU

Status
Recruiting
Phase
Locations
Egypt
Study Type
Observational
Intervention
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Critically Ill Childern in PICU

Eligibility Criteria

1 Month - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

critically-ill childern

Arm Description

Outcomes

Primary Outcome Measures

Abnormalities detecred in Holter monitoring of critically-ill childern
the relation between abnormalities detected in Holter and prognosis of critically-ill childern
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.
Arrhythmia detected in critically-ill childern
arrhythmia detected in Holter of critically ill childern whom have any critical illness

Secondary Outcome Measures

Full Information

First Posted
March 13, 2022
Last Updated
March 28, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05312333
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Childern in PICU

7. Study Design

Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
critically-ill childern
Primary Outcome Measure Information:
Title
Abnormalities detecred in Holter monitoring of critically-ill childern
Description
the relation between abnormalities detected in Holter and prognosis of critically-ill childern
Time Frame
one year
Title
The relation between heart rate variability and outcome ,prognosis of illness
Description
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.
Time Frame
one year
Title
Arrhythmia detected in critically-ill childern
Description
arrhythmia detected in Holter of critically ill childern whom have any critical illness
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Study Population Description
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.
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ElSherif, professor
Email
portal@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16472287
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.
Results Reference
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PubMed Identifier
31100075
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.
Results Reference
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PubMed Identifier
23685639
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.
Results Reference
background
PubMed Identifier
11286528
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.
Results Reference
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Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital

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