Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613464
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
The Impact of POCUS on Treatment Planning and Prognosis in the ICU
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Point-of-care Ultrasound on Treatment Planning and Prognosis in the Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to understand how using bedside ultrasound in the intensive care unit ICU can improve diagnosis and treatment for critically ill patients When patients are admitted to the ICU doctors usually rely on various tests and assessments such as the APACHE-II score to estimate the severity of their condition and predict their chances of survival In addition to these tests we will use bedside ultrasound to examine the lungs heart vena cava a large vein and optic nerve which can give us important information about the patients condition
By using ultrasound we can look for things like fluid in the lungs heart function or increased pressure in the brain Based on what we find with the ultrasound we may adjust treatments such as changing the amount of fluids given or starting new medications
We will also compare each patients condition on the first day and the fifth day using both ultrasound findings and their APACHE-II score to see if the ultrasound results have influenced their care and outcomes The study will include 40 patients and we will track their progress including how long they stay on mechanical ventilation how long they are in the hospital and their survival after 28 days
This research will help us learn more about how ultrasound can help doctors make better decisions in the ICU leading to improved care for critically ill patients
By using ultrasound we can look for things like fluid in the lungs heart function or increased pressure in the brain Based on what we find with the ultrasound we may adjust treatments such as changing the amount of fluids given or starting new medications
We will also compare each patients condition on the first day and the fifth day using both ultrasound findings and their APACHE-II score to see if the ultrasound results have influenced their care and outcomes The study will include 40 patients and we will track their progress including how long they stay on mechanical ventilation how long they are in the hospital and their survival after 28 days
This research will help us learn more about how ultrasound can help doctors make better decisions in the ICU leading to improved care for critically ill patients
Detailed Description:
Detailed Description for Clinical Trials
This prospective observational study focuses on the routine use of point-of-care ultrasound POCUS in the intensive care unit ICU and its impact on diagnosis treatment decisions and patient outcomes Bedside ultrasound is increasingly recommended in ICU settings because it provides non-invasive repeatable and immediate diagnostic information that can guide the management of critically ill patients
Upon admission all ICU patients will undergo an initial assessment including routine tests such as the APACHE-II score which helps to estimate the severity of illness and predict the likelihood of survival The goal of this study is to evaluate how POCUS in addition to standard care influences patient outcomes and whether it provides any additional diagnostic information that changes the treatment plan
Key components of the study include
1 Initial Evaluation
All patients will have their medical history taken undergo a physical examination and have blood tests performed which are standard for ICU patients These will be used to calculate the APACHE-II score
In addition to routine care each patient will be evaluated with POCUS including
Lung Ultrasound LUS The lungs will be divided into six regions upper and lower parts of the anterior lateral and posterolateral thoracic walls to check for conditions such as lung consolidation edema pleural effusion or pneumothorax
Cardiac Ultrasound The heart will be examined for valvular pathologies fractional shortening FS pericardial effusion and inferior vena cava IVC diameter to assess volume status using the collapsibility and distensibility index
Optic Nerve Ultrasound The optic nerve sheath diameter will be measured to evaluate intracranial pressure
2 Changes in Diagnosis and Treatment
Based on the findings from the ultrasound the treatment plan may be modified For example if the ultrasound reveals fluid overload or inadequate volume the amount of intravenous fluids may be adjusted If lung ultrasound shows consolidations adjustments to patient positioning or additional interventions may be made Similarly changes in cardiac ultrasound may result in modifying inotropic or vasodilator therapy and optic nerve measurements may influence treatments for brain edema
After 5 days the patients will undergo another ultrasound and their APACHE-II score will be recalculated to assess the effectiveness of the treatments and any changes in patient prognosis
3 Outcome Measurement
The study will follow 40 patients over a 28-day period Outcomes will be evaluated by comparing the initial and subsequent ultrasound findings changes in treatment and the predicted mortality rates based on the APACHE-II score
Secondary outcomes will include the duration of mechanical ventilation length of ICU stay and 28-day mortality
The study will also assess the impact of ultrasound on specific organ systems
Respiratory System LUS PaO2FiO2 ratio and PaCO2 levels will be monitored to assess lung function
Cardiovascular System Intravascular volume will be evaluated using vena cava ultrasound while heart failure will be assessed with FS and LUS scores
Intracranial Pressure The optic nerve sheath diameter will be used to monitor changes in intracranial pressure
The primary objective of this study is to determine whether bedside ultrasound can provide additional diagnostic information that significantly impacts treatment decisions and improves patient outcomes in the ICU The secondary aim is to evaluate the effect of ultrasound on the functionality of different organ systems and how it contributes to overall patient prognosis and survival
This prospective observational study focuses on the routine use of point-of-care ultrasound POCUS in the intensive care unit ICU and its impact on diagnosis treatment decisions and patient outcomes Bedside ultrasound is increasingly recommended in ICU settings because it provides non-invasive repeatable and immediate diagnostic information that can guide the management of critically ill patients
Upon admission all ICU patients will undergo an initial assessment including routine tests such as the APACHE-II score which helps to estimate the severity of illness and predict the likelihood of survival The goal of this study is to evaluate how POCUS in addition to standard care influences patient outcomes and whether it provides any additional diagnostic information that changes the treatment plan
Key components of the study include
1 Initial Evaluation
All patients will have their medical history taken undergo a physical examination and have blood tests performed which are standard for ICU patients These will be used to calculate the APACHE-II score
In addition to routine care each patient will be evaluated with POCUS including
Lung Ultrasound LUS The lungs will be divided into six regions upper and lower parts of the anterior lateral and posterolateral thoracic walls to check for conditions such as lung consolidation edema pleural effusion or pneumothorax
Cardiac Ultrasound The heart will be examined for valvular pathologies fractional shortening FS pericardial effusion and inferior vena cava IVC diameter to assess volume status using the collapsibility and distensibility index
Optic Nerve Ultrasound The optic nerve sheath diameter will be measured to evaluate intracranial pressure
2 Changes in Diagnosis and Treatment
Based on the findings from the ultrasound the treatment plan may be modified For example if the ultrasound reveals fluid overload or inadequate volume the amount of intravenous fluids may be adjusted If lung ultrasound shows consolidations adjustments to patient positioning or additional interventions may be made Similarly changes in cardiac ultrasound may result in modifying inotropic or vasodilator therapy and optic nerve measurements may influence treatments for brain edema
After 5 days the patients will undergo another ultrasound and their APACHE-II score will be recalculated to assess the effectiveness of the treatments and any changes in patient prognosis
3 Outcome Measurement
The study will follow 40 patients over a 28-day period Outcomes will be evaluated by comparing the initial and subsequent ultrasound findings changes in treatment and the predicted mortality rates based on the APACHE-II score
Secondary outcomes will include the duration of mechanical ventilation length of ICU stay and 28-day mortality
The study will also assess the impact of ultrasound on specific organ systems
Respiratory System LUS PaO2FiO2 ratio and PaCO2 levels will be monitored to assess lung function
Cardiovascular System Intravascular volume will be evaluated using vena cava ultrasound while heart failure will be assessed with FS and LUS scores
Intracranial Pressure The optic nerve sheath diameter will be used to monitor changes in intracranial pressure
The primary objective of this study is to determine whether bedside ultrasound can provide additional diagnostic information that significantly impacts treatment decisions and improves patient outcomes in the ICU The secondary aim is to evaluate the effect of ultrasound on the functionality of different organ systems and how it contributes to overall patient prognosis and survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None