Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05400343
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-05-27
Brief Title:
Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Traumatic brain injury TBI is a leading cause of death and disability in trauma patients As the primary injury cannot be reversed management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia and maintaining appropriate cerebral perfusion pressure CPP which is a surrogate for cerebral blood flow CBF The goal should be euvolemia and avoidance of hypotension The assessment of a patients body fluid status is a challenging task for modern clinicians
The use of Ultrasonography to assess body fluids has numerous advantages The concept of using lung ultrasound for monitoring the patient is one of the major innovations that emerged from recent studies Pulmonary congestion may be semiquantified using lung ultrasound and deciding how the patient tolerates fluid Inferior vena cava IVC sonography and point-of-care ultrasound POCUS has become widely used as a tool to help clinicians prescribe fluid therapy Common POCUS applications that serve as guides to fluid administration rely on assessments of the inferior vena cava to estimate preload and lung ultrasound to identify the early presence of extravascular lung water and avoid fluid over resuscitation In this study we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI We will also use ONSD as a mirror for intra-cranial pressure ICP
The use of Ultrasonography to assess body fluids has numerous advantages The concept of using lung ultrasound for monitoring the patient is one of the major innovations that emerged from recent studies Pulmonary congestion may be semiquantified using lung ultrasound and deciding how the patient tolerates fluid Inferior vena cava IVC sonography and point-of-care ultrasound POCUS has become widely used as a tool to help clinicians prescribe fluid therapy Common POCUS applications that serve as guides to fluid administration rely on assessments of the inferior vena cava to estimate preload and lung ultrasound to identify the early presence of extravascular lung water and avoid fluid over resuscitation In this study we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI We will also use ONSD as a mirror for intra-cranial pressure ICP
Detailed Description:
The aim of this study is to detect the effectiveness of using IVC and lung ultrasound as bedside tools to ensure euvolemia in patients with traumatic brain injuries
Positive fluid balances have been associated with angiographic vasospasm longer hospital length of stay and poor functional outcomes The assessment of a patients body fluid status is a challenging task for modern clinicians Currently the most accurate method to guide fluid administration decisions uses dynamic measures that estimate the change in cardiac output that would occur in response to a fluid bolus Unfortunately their use remains limited due to required technical expertise costly equipment or applicability in only a subset of patients Alternatively point-of-care ultrasound POCUS has become widely used as a tool to help clinicians prescribe fluid therapy
International recommendations suggest that the inferior vena cava IVC can be assessed to estimate the pressure in the right atrium of non-ventilated patients because of its collapsibility during inspiration An IVC diameter of 21mm with collapsibility of 50 during inspiration suggests normal right atrium pressure between 0 and 5 mmHg whereas a diameter of 21mm with collapsibility of 50 suggests high pressure between 10 and 20mmHg The dynamic method of IVC evaluation based on the variation in its diameter with respiration enables the assessment of the potential benefit of fluid administration as a function of IVC compliance
Ultrasonography of optic nerve sheath diameter ONSD in TBI patients has been shown to correlate with increased ICP and systemic reviews have supported this observation
In this study we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI We will also use ONSD as a mirror for ICP
The study investigates the effect of using bedside sonography in fluid assessment in a critically ill patient
Positive fluid balances have been associated with angiographic vasospasm longer hospital length of stay and poor functional outcomes The assessment of a patients body fluid status is a challenging task for modern clinicians Currently the most accurate method to guide fluid administration decisions uses dynamic measures that estimate the change in cardiac output that would occur in response to a fluid bolus Unfortunately their use remains limited due to required technical expertise costly equipment or applicability in only a subset of patients Alternatively point-of-care ultrasound POCUS has become widely used as a tool to help clinicians prescribe fluid therapy
International recommendations suggest that the inferior vena cava IVC can be assessed to estimate the pressure in the right atrium of non-ventilated patients because of its collapsibility during inspiration An IVC diameter of 21mm with collapsibility of 50 during inspiration suggests normal right atrium pressure between 0 and 5 mmHg whereas a diameter of 21mm with collapsibility of 50 suggests high pressure between 10 and 20mmHg The dynamic method of IVC evaluation based on the variation in its diameter with respiration enables the assessment of the potential benefit of fluid administration as a function of IVC compliance
Ultrasonography of optic nerve sheath diameter ONSD in TBI patients has been shown to correlate with increased ICP and systemic reviews have supported this observation
In this study we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI We will also use ONSD as a mirror for ICP
The study investigates the effect of using bedside sonography in fluid assessment in a critically ill patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None