- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06672783
Impact of Focused Echocardiography in Management of Patients in Pediatric Intensive Care Units
November 1, 2024 updated by: Doaa Hassan Ahmed, Sohag University
Echocardiography is currently considered a key tool for the hemodynamic assessment in Intensive Care Units (ICU), able to identify causes of hemodynamic instability and to quickly guide therapy .
Some of its advantages are being a noninvasive method, risk-free, capable of being performed serially and in real time, and analyzed along with clinical data by intensivists.
Several studies have demonstrated the positive effect of the use of echocardiography in the management of critically ill patients, changing their treatment in 30%-60% of cases after the test is performed .
Echocardiography has been used as an adjunct in predicting patient outcomes.
Relevant and easily obtain-able information about hemodynamics is required for effective therapeutic manipulation of circulation in critically ill children ,Hemodynamic monitoring of critically ill infants and children noninvasively using echocardiography has been evaluated comprehensively Echocardiography is an influential procedure that allows direct visualization of the heart, guiding patients' hemodynamic condition at the bedside.
This hemodynamic estimate informs physicians to guide therapeutic approaches like volume resuscitation, initiation, discontinuation, alteration of vasopressor therapy and referral for specialist rapidly if cardiac or surgical attempt is necessary Management of critically ill pediatric patients is a demanding task that requires proper prioritization and judicious time management.
Multi-system affection with overlap of symptoms often complicates the clinical picture.
Hemodynamic assessment has recently taken top priority in the management of critically ill patients, Echocardiography is an integral component of the clinical service in the pediatric intensive care unit (PICU).
It is considered a handy bedside imaging modality, and an accurate diagnostic tool that explores a crucial body system.
Indications of bedside echocardiography in TINEC (training in intensive care and neonatal echocardiography) include assessing cardiac function, pulmonary hypertension, severe pericardial effusion, and tamponade.
Consequently, it serves as a guide for interventions in critically ill pediatric patients and management .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: safaa H Ali, professor
Study Contact Backup
- Name: doaa H Ahmed, resident
- Phone Number: 01118226083
- Email: duaa.hassan@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt, Sohag
- Sohag University Hospital
-
Contact:
- Magdy M Amin, professor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- All critically ill patients admitted to pediatric intensive care units aged from 1 month Up to 18 years old.
Exclusion Criteria:
- non crtical ill patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of focused echocardiography in management of patients in pediatric intensive care units
Time Frame: Through study completion , an average of one year
|
functional echocardiography (ejection fraction using M mode echocardiography .
|
Through study completion , an average of one year
|
|
Impact of focused echocardiography in management of patients in pediatric intensive care units
Time Frame: Through study completion , an average of one year
|
Functional echocardiography (fraction shortening by M mode echocardiography .
|
Through study completion , an average of one year
|
|
Impact of focused echocardiography in management of patients in pediatric intensive care units
Time Frame: Through study completion , an average of one year
|
Assessment of pulmonary hypertension using peak tricuspid regurgitation velocity by color Doppler .
|
Through study completion , an average of one year
|
|
Impact of focused echocardiography in management of patients in pediatric intensive care units
Time Frame: Through study completion , an average of one year
|
assessment of myocardial performance index.
|
Through study completion , an average of one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Manasia AR, Nagaraj HM, Kodali RB, Croft LB, Oropello JM, Kohli-Seth R, Leibowitz AB, DelGiudice R, Hufanda JF, Benjamin E, Goldman ME. Feasibility and potential clinical utility of goal-directed transthoracic echocardiography performed by noncardiologist intensivists using a small hand-carried device (SonoHeart) in critically ill patients. J Cardiothorac Vasc Anesth. 2005 Apr;19(2):155-9. doi: 10.1053/j.jvca.2005.01.023.
- Ranjit S, Aram G, Kissoon N, Ali MK, Natraj R, Shresti S, Jayakumar I, Gandhi D. Multimodal monitoring for hemodynamic categorization and management of pediatric septic shock: a pilot observational study*. Pediatr Crit Care Med. 2014 Jan;15(1):e17-26. doi: 10.1097/PCC.0b013e3182a5589c.
- Vieillard-Baron A, Prin S, Chergui K, Dubourg O, Jardin F. Hemodynamic instability in sepsis: bedside assessment by Doppler echocardiography. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1270-6. doi: 10.1164/rccm.200306-816CC. No abstract available.
- Croft LB, Duvall WL, Goldman ME. A pilot study of the clinical impact of hand-carried cardiac ultrasound in the medical clinic. Echocardiography. 2006 Jul;23(6):439-46. doi: 10.1111/j.1540-8175.2006.00240.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2024
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
October 9, 2024
First Submitted That Met QC Criteria
November 1, 2024
First Posted (Estimated)
November 4, 2024
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
November 1, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- soh-Med-24-09-06MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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