Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04866095
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2021-04-26
Brief Title:
Inferior Vena Cava Compliance in Trans-thoracic Echocardiography is the Trans-hepatic Window as Reliable as the Subcostal One
Sponsor:
Brugmann University Hospital
Organization:
Brugmann University Hospital
Study Overview
Official Title:
Inferior Vena Cava Compliance in Trans-thoracic Echocardiography is the Trans-hepatic Window as Reliable as the Subcostal One
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
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:
The ability to assess intravascular volume is an essential part of perioperative care insufficient intravascular volume can result in decreased oxygen delivery to tissues and organ dysfunction while fluid overload can contribute to the development of oedema organ dysfunction respiratory failure and healing defect
At the present state there are many different methods of interpreting intravascular circulating blood volume Non-invasive techniques such as the Clear Sight System and the transthoracic echocardiogram TTE have been proposed as non-invasive methods to assess patient blood volume
The aim of this study is to assess whether the measure of the inferior vena cava IVC in the trans-hepatic window is as reliable as in the subcostal window to determine fluid responsiveness in perioperative patients In this study preload increase will be obtained through passive leg raising Sensibility and specificity of the two echocardiographic approaches to predict fluid responsiveness will be compared while using the subcostal window as the gold standard The effect of passive leg elevation on patients cardiac output response will be assessed with two different non-invasive techniques the Clear Sight system and the TTE
At the present state there are many different methods of interpreting intravascular circulating blood volume Non-invasive techniques such as the Clear Sight System and the transthoracic echocardiogram TTE have been proposed as non-invasive methods to assess patient blood volume
The aim of this study is to assess whether the measure of the inferior vena cava IVC in the trans-hepatic window is as reliable as in the subcostal window to determine fluid responsiveness in perioperative patients In this study preload increase will be obtained through passive leg raising Sensibility and specificity of the two echocardiographic approaches to predict fluid responsiveness will be compared while using the subcostal window as the gold standard The effect of passive leg elevation on patients cardiac output response will be assessed with two different non-invasive techniques the Clear Sight system and the TTE
Detailed Description:
The ability to assess intravascular volume is an essential part of perioperative care insufficient intravascular volume can result in decreased oxygen delivery to tissues and organ dysfunction while fluid overload can contribute to the development of oedema organ dysfunction respiratory failure and healing defect
Assessment of the volume status in perioperative patients relies on two important concepts euvolemia and fluid responsiveness
Euvolemia describes a state of adequate circulating blood volume that allows suitable filling of the cardiac chambers making possible for the heart to produce a cardiac output that meets the peripheral oxygen demand
Fluid responsiveness describes the ability of the heart to adapt blood flow in response to preload increase
As euvolemia is the ultimate goal of fluid administration then evaluating fluid responsiveness reflects the process of working toward establishing euvolemia
At the present state there are many different methods of interpreting intravascular circulating blood volume those related to pressures measurements the central venous pressure CVP the pulmonary artery occluded pressure PAOP and those related to cardiac output measurements like thermodilution and pulse contour techniques It is worth noting that all these are invasive methods that expose patients to a series of possible side effects such as pneumothorax infections hematomas and vascular lesions Non-invasive techniques such as the Clear Sight System and the transthoracic echocardiogram TTE have been proposed as non-invasive methods to assess patient blood volume
TTE is a widely used and validated imaging technique which involves the study of the heart and great vessels through multiple examination windows
In particular the subcostal window represents the gold standard for evaluating the diameter of the inferior vena cava IVC and its compliance allowing the physician to obtain valuable information on the volume status of patients several studies have reported that these measurements could predict accurately the hemodynamic response of patient to a change in cardiac preload However acquiring images in the subcostal window can be in some cases difficult or impossible due to the presence of drainages or surgical wounds in such cases an alternative could be represented by the trans-hepatic window which at the best of the investigators knowledge it has never been validated in the literature
The Clear Sight System is a non-invasive blood pressure BP monitoring system where the CO is determined analysing the photo-plethysmography curve by a miniaturized pressure cuff and infrared LEDs
Its main advantage is to assess CO continuously in a completely non-invasive way following its variations and thereby contributing to the detection of hypovolaemia Other visualized parameters are the stroke volume SV the systemic vascular resistance SVR as well as the BP and the heart rate HR
Passive leg raising PLR is a test developed to predict patients hemodynamic response to increase preload without any fluid administration Raising the patient from a semi-recumbent position to a position with the head at 0 and the legs raised to a 45 angle is associated with about 300 ml of blood volume mobilization from the lower limbs and splanchnic territory to the central compartment resulting in increased venous return to the heart This manoeuvre provokes a preload increase to which patients could respond with responder or without non-responders an augmentation of their cardiac output
The aim of this study is to assess whether the measure of the IVC in the trans-hepatic window is as reliable as in the subcostal window to determine fluid responsiveness in perioperative patients In this study preload increase will be obtained through passive leg raising Sensibility and specificity of the two echocardiographic approaches to predict fluid responsiveness will be compared while using the subcostal window as the gold standard The effect of passive leg elevation on patients cardiac output response will be assessed with two different non-invasive techniques the Clear Sight system and the TTE
Assessment of the volume status in perioperative patients relies on two important concepts euvolemia and fluid responsiveness
Euvolemia describes a state of adequate circulating blood volume that allows suitable filling of the cardiac chambers making possible for the heart to produce a cardiac output that meets the peripheral oxygen demand
Fluid responsiveness describes the ability of the heart to adapt blood flow in response to preload increase
As euvolemia is the ultimate goal of fluid administration then evaluating fluid responsiveness reflects the process of working toward establishing euvolemia
At the present state there are many different methods of interpreting intravascular circulating blood volume those related to pressures measurements the central venous pressure CVP the pulmonary artery occluded pressure PAOP and those related to cardiac output measurements like thermodilution and pulse contour techniques It is worth noting that all these are invasive methods that expose patients to a series of possible side effects such as pneumothorax infections hematomas and vascular lesions Non-invasive techniques such as the Clear Sight System and the transthoracic echocardiogram TTE have been proposed as non-invasive methods to assess patient blood volume
TTE is a widely used and validated imaging technique which involves the study of the heart and great vessels through multiple examination windows
In particular the subcostal window represents the gold standard for evaluating the diameter of the inferior vena cava IVC and its compliance allowing the physician to obtain valuable information on the volume status of patients several studies have reported that these measurements could predict accurately the hemodynamic response of patient to a change in cardiac preload However acquiring images in the subcostal window can be in some cases difficult or impossible due to the presence of drainages or surgical wounds in such cases an alternative could be represented by the trans-hepatic window which at the best of the investigators knowledge it has never been validated in the literature
The Clear Sight System is a non-invasive blood pressure BP monitoring system where the CO is determined analysing the photo-plethysmography curve by a miniaturized pressure cuff and infrared LEDs
Its main advantage is to assess CO continuously in a completely non-invasive way following its variations and thereby contributing to the detection of hypovolaemia Other visualized parameters are the stroke volume SV the systemic vascular resistance SVR as well as the BP and the heart rate HR
Passive leg raising PLR is a test developed to predict patients hemodynamic response to increase preload without any fluid administration Raising the patient from a semi-recumbent position to a position with the head at 0 and the legs raised to a 45 angle is associated with about 300 ml of blood volume mobilization from the lower limbs and splanchnic territory to the central compartment resulting in increased venous return to the heart This manoeuvre provokes a preload increase to which patients could respond with responder or without non-responders an augmentation of their cardiac output
The aim of this study is to assess whether the measure of the IVC in the trans-hepatic window is as reliable as in the subcostal window to determine fluid responsiveness in perioperative patients In this study preload increase will be obtained through passive leg raising Sensibility and specificity of the two echocardiographic approaches to predict fluid responsiveness will be compared while using the subcostal window as the gold standard The effect of passive leg elevation on patients cardiac output response will be assessed with two different non-invasive techniques the Clear Sight system and the TTE
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