All of the Icu Patients Over 18 Years Old Except Pregnant, Trauma and AKI PatientsNCT06613464
The Impact of POCUS on Treatment Planning and Prognosis in the ICU
An observational study of All of the Icu Patients Over 18 Years Old Except Pregnant, Trauma and AKI Patients, run by Döndü Genc Moralar at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All of the Icu Patients Over 18 Years Old Except Pregnant, Trauma and AKI Patients
- What is being tested?
- diagnosis confirmation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2023to 2 Jan 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to intensive care over the age of 18 and who have been in intensive care for more than 5 days
Who may be able to join
- Patients over the age of 18 who are admitted to intensive care
- Patients who have been in intensive care for more than 5 days
Who cannot join
- Being pregnant
- Patients with head trauma
- Acute renal failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul, 34255
About this study
Official title: The Impact of Point-of-care Ultrasound on Treatment Planning and Prognosis in the Intensive Care Unit
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 patient's 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.
Read more
We will also compare each patient's 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.
Read the 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:
- 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.
- 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.
- 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, PaO2/FiO2 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.
- Being tested
- diagnosis confirmation
- Keywords
- POCUS, Ultrasound, Mortality
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis confirmationDiagnostic test
The patients diagnoses will be confirmed though imaging methods like computed tomography chest x-ray and anamnesis
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Patients over the age of 18 who are admitted to intensive care unit and who have been in intensive care for >5 days Receives: Diagnostic Test: diagnosis confirmation |
What is being measured
The primary outcome is the main question the study is designed to answer.
POCUS effectiveness
The primary goal of our study is to evaluate the effectiveness of point-of-care ultrasound (POCUS) in the diagnosis and treatment of patients admitted to the intensive care unit (ICU). We aim to investigate how the use of ultrasound alters diagnostic clarity and treatment interventions compared to initial diagnoses made without ultrasound. Any new or additional diagnoses made following ultrasound will be considered supplemental findings, which may lead to changes in the treatment plan.
Measured: First 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start16 Aug 2023
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for All of the Icu Patients Over 18 Years Old Except Pregnant, Trauma and AKI PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Döndü Genc Moralar
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613464
- Sponsor's protocol ID
- 88
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pontet J, Yic C, Diaz-Gomez JL, Rodriguez P, Sviridenko I, Mendez D, Noveri S, Soca A, Cancela M. Impact of an ultrasound-driven diagnostic protocol at early intensive-care stay: a randomized-controlled trial. Ultrasound J. 2019 Sep 30;11(1):24. doi: 10.1186/s13089-019-0139-2.
PubMed 31595353Manno E, Navarra M, Faccio L, Motevallian M, Bertolaccini L, Mfochive A, Pesce M, Evangelista A. Deep impact of ultrasound in the intensive care unit: the "ICU-sound" protocol. Anesthesiology. 2012 Oct;117(4):801-9. doi: 10.1097/ALN.0b013e318264c621.
PubMed 22990179
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Point-of-care Ultrasound on Treatment Planning and Prognosis in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06613464
- Acronym / sponsor ID
- 88
- Keywords
- POCUS, Ultrasound, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Döndü Genc MoralarOther government
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 26 Sep 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.
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 patient's 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 patient's 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:
- 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.
- 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.
- 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, PaO2/FiO2 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Diagnostic Test: diagnosis confirmationPatients over the age of 18 who are admitted to intensive care unit and who have been in intensive care for >5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care over the age of 18 and who have been in intensive care for more than 5 days
Key inclusion criteria (2 listed)
- Patients over the age of 18 who are admitted to intensive care
- Patients who have been in intensive care for more than 5 days
Key exclusion criteria (3 listed)
- Being pregnant
- Patients with head trauma
- Acute renal failure
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 |
|---|---|---|
| diagnosis confirmationThe patients diagnoses will be confirmed though imaging methods like computed tomography chest x-ray and anamnesis | Diagnostic test | ICU patients |
Primary outcome
POCUS effectiveness
Time frame: First 5 days
The primary goal of our study is to evaluate the effectiveness of point-of-care ultrasound (POCUS) in the diagnosis and treatment of patients admitted to the intensive care unit (ICU). We aim to investigate how the use of ultrasound alters diagnostic clarity and treatment interventions compared to initial diagnoses made without ultrasound. Any new or additional diagnoses made following ultrasound will be considered supplemental findings, which may lead to changes in the treatment plan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 31595353Pontet J, Yic C, Diaz-Gomez JL, Rodriguez P, Sviridenko I, Mendez D, Noveri S, Soca A, Cancela M. Impact of an ultrasound-driven diagnostic protocol at early intensive-care stay: a randomized-controlled trial. Ultrasound J. 2019 Sep 30;11(1):24. doi: 10.1186/s13089-019-0139-2.
- Background: PubMed 22990179Manno E, Navarra M, Faccio L, Motevallian M, Bertolaccini L, Mfochive A, Pesce M, Evangelista A. Deep impact of ultrasound in the intensive care unit: the "ICU-sound" protocol. Anesthesiology. 2012 Oct;117(4):801-9. doi: 10.1097/ALN.0b013e318264c621.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All of the Icu Patients Over 18 Years Old Except Pregnant, Trauma and AKI Patients, run by Döndü Genc Moralar at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 26 Sep 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POCUS effectiveness (time frame: First 5 days). 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 NCT06613464, which also lists 2 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 26 Sep 2024.