Critical Patients in Pediatric Intesive CareNCT06672783
Impact of Focused Echocardiography in Management of Patients in Pediatric Intensive Care Units
A study testing echocardiogrphy in people with Critical Patients in Pediatric Intesive Care, run by Sohag University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Critical Patients in Pediatric Intesive Care
- What is being tested?
- echocardiogrphy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All critically ill patients admitted to pediatric intensive care units aged from 1 month Up to 18 years old.
Who cannot join
- non crtical ill patients
Trial locations and contacts
1 site in 1 country.
safaa H Ali, professor contact
About this study
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 .
- Being tested
- echocardiogrphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiogrphyProcedure or surgery
Transthoracic echocardiography
- Parameters assessed:
- Right ventricular dimensions and function
- Pulmonary artery pressure estimation
- Valvular function assessment
- Left ventricular dimensions (end-diastolic and end-systolic)o Left ventricular function (ejection fraction, fractional shortening) o
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of focused echocardiography in management of patients in pediatric intensive care units
functional echocardiography (ejection fraction using M mode echocardiography .
Measured: Through study completion , an average of one year
Impact of focused echocardiography in management of patients in pediatric intensive care units
Functional echocardiography (fraction shortening by M mode echocardiography .
Measured: Through study completion , an average of one year
Impact of focused echocardiography in management of patients in pediatric intensive care units
Assessment of pulmonary hypertension using peak tricuspid regurgitation velocity by color Doppler .
Measured: Through study completion , an average of one year
Impact of focused echocardiography in management of patients in pediatric intensive care units
assessment of myocardial performance index.
Measured: Through study completion , an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical Patients in Pediatric Intesive CareStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Hassan Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672783
- Sponsor's protocol ID
- soh-Med-24-09-06MS
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 14644922Croft 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.
PubMed 16839380Manasia 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.
PubMed 15868520Ranjit 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.
PubMed 24196006
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Focused Echocardiography in Management of Patients in Pediatric Intensive Care Units
- ClinicalTrials.gov ID
- NCT06672783
- Acronym / sponsor ID
- soh-Med-24-09-06MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All critically ill patients admitted to pediatric intensive care units aged from 1 month Up to 18 years old.
Key exclusion criteria (1 listed)
- non crtical ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiogrphyTransthoracic echocardiography • Parameters assessed: * Right ventricular dimensions and function * Pulmonary artery pressure estimation * Valvular function assessment * Left ventricular dimensions (end-diastolic and end-systolic)o Left ventricular function (ejection fraction, fractional shortening) o | Procedure or surgery | – |
Primary outcome
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 .
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 .
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 .
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 14644922Vieillard-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.
- Background: PubMed 16839380Croft 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.
- Background: PubMed 15868520Manasia 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.
- Background: PubMed 24196006Ranjit 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
safaa H Ali, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echocardiogrphy in people with Critical Patients in Pediatric Intesive Care, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact doaa H Ahmed, resident (01118226083, duaa.hassan@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of focused echocardiography in management of patients in pediatric intensive care units (time frame: Through study completion , an average of one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06672783, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.