Surgical Procedure, UnspecifiedNCT04866095
Inferior Vena Cava Compliance in Trans-thoracic Echocardiography: is the Trans-hepatic Window as Reliable as the Subcostal One
A study testing Transthoracic echocardiogram and Clear Sight system in people with Surgical Procedure, Unspecified, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Transthoracic echocardiogram and Clear Sight system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jun 2021to 9 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of the CHU Brugmann hospital, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality TTE imaging without pain and discomfort.
- Examples of such surgeries are:
- Orthopaedic surgery: interventions of upper limbs.
- Stomatology: dental extractions
- Gastroenterology: oesophagus gastroscopy
- Maxillo-facial surgery: septoplasties, rhinoplasties, Le Fort surgeries
Show all 9Show fewer
- ENT surgery: thyroidectomy, sleep endoscopies
- Gynaecology: hysteroscopy, voluntary terminations of pregnancy
- Ophthalmic surgery
Who cannot join
- Refusal to participate to the study
- suboptimal image acquisition
- atrial fibrillation, patients with 6 or more extra systoles per minute
- cardiac valvular pathologies
- TTE imaging causing pain and/or discomfort to the patient
- surgeries that don't allow obtaining high quality imaging, elevated intra-abdominal pressure.
Trial locations and contacts
1 site in 1 country.
About this study
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 patient's cardiac output response will be assessed with two different non-invasive techniques: the Clear Sight system and the TTE.
Read the 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 investigator's 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 patient's 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 patient's cardiac output response will be assessed with two different non-invasive techniques: the Clear Sight system and the TTE.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Transthoracic echocardiogram, Clear Sight system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiogramDevice
Transthoracic echocardiogram (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. Acquiring images in the subcostal window with a transthoracic echocardiogram (TTE) 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. This has not been validated in the scientific litterature.
Clear Sight systemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | All patients, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality transthoracic echocardiogram imaging without pain and discomfort. Receives: Device: Transthoracic echocardiogram; Device: Clear Sight system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE
Comparison of the sensitivity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.
Measured: 20 minutes
Difference of specificity between the trans-hepatic window versus the subcostal window with TTE
Comparison of the specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.
Measured: 20 minutes
Secondary outcomes (5)
Difference of sensitivity between the trans-hepatic window versus the subcostal window with the Clear Sight system
Comparison of the sensitivity and specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response (with the Clear Sight system) to passive leg raising.
Measured: 20 minutes
Difference of specificity between the trans-hepatic window versus the subcostal window with the Clear Sight system
Comparison of the sensitivity and specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response (with the Clear Sight system) to passive leg raising.
Measured: 20 minutes
Right atrial pressure (RA)- trans-hepatic window
Evaluation of the estimation of RA pressure obtained with the trans-hepatic and sub-costal approaches
Measured: 20 minutes
Right atrial pressure (RA) - subcostal window
Evaluation of the estimation of RA pressure obtained with the trans-hepatic and sub-costal approaches
Measured: 20 minutes
Cardiac output
Cardiac output calculated by: CO= sub-Aortic Velocity Time Integral (sAoVTI) × heart rate in beats per minute (bpm) × left ventricular outflow track (LVOT)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start25 Jun 2021
- Primary completion30 Oct 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
- Investigators
- Francesco Zuccarini, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866095
- Sponsor's protocol ID
- CHUB-WICAVE
- Status last verified
- Nov 2021
- First submitted
- 26 Apr 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava Compliance in Trans-thoracic Echocardiography: is the Trans-hepatic Window as Reliable as the Subcostal One
- ClinicalTrials.gov ID
- NCT04866095
- Acronym / sponsor ID
- CHUB-WICAVE
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 29 Apr 2021 (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.
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 patient's 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 investigator's 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 patient's 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 patient's cardiac output response will be assessed with two different non-invasive techniques: the Clear Sight system and the TTE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Device: Transthoracic echocardiogram, Device: Clear Sight systemAll patients, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality transthoracic echocardiogram imaging without pain and discomfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients of the CHU Brugmann hospital, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality TTE imaging without pain and discomfort.
- Orthopaedic surgery: interventions of upper limbs.
- Stomatology: dental extractions
- Gastroenterology: oesophagus gastroscopy
- Maxillo-facial surgery: septoplasties, rhinoplasties, Le Fort surgeries
Key exclusion criteria (6 listed)
- Refusal to participate to the study
- suboptimal image acquisition
- atrial fibrillation, patients with 6 or more extra systoles per minute
- cardiac valvular pathologies
- TTE imaging causing pain and/or discomfort to the patient
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 |
|---|---|---|
| Transthoracic echocardiogramTransthoracic echocardiogram (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. Acquiring images in the subcostal window with a transthoracic echocardiogram (TTE) 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. This has not been validated in the scientific litterature. | Device | Surgery |
| Clear Sight systemThe 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). | Device | Surgery |
Primary outcome
Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE
Time frame: 20 minutes
Comparison of the sensitivity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.
Difference of specificity between the trans-hepatic window versus the subcostal window with TTE
Time frame: 20 minutes
Comparison of the specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.
5 secondary outcomes
Difference of sensitivity between the trans-hepatic window versus the subcostal window with the Clear Sight system
Time frame: 20 minutes
Difference of specificity between the trans-hepatic window versus the subcostal window with the Clear Sight system
Time frame: 20 minutes
Right atrial pressure (RA)- trans-hepatic window
Time frame: 20 minutes
Right atrial pressure (RA) - subcostal window
Time frame: 20 minutes
Cardiac output
Time frame: 20 minutes
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 10 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Francesco Zuccarini principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echocardiogram and Clear Sight system in people with Surgical Procedure, Unspecified, run by Brugmann University Hospital at 1 site in Belgium.
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 9 inclusion and 6 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 10 Nov 2021. 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 Belgium. 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?
Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2021.