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
About this trial
This is an observational trial for Critically Ill Childern in PICU
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.
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
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
background
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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