PregnancyesCCONCT02255448
Evaluation of the esCCO Non-invasive Cardiac Output Measurement Device in Pregnancy
A study testing Transthoracic echo and esCCO stroke volume in people with Pregnancy, run by King's College Hospital NHS Trust.
Trial summary
Cardiac output (CO) is the volume of blood ejected from the heart and is a product of stroke volume (SV) vs heart rate (HR). It is closely related to Blood Pressure (BP) by the formula CO = Mean Arterial Pressure (MAP) / Systemic Vascular Resistance (SVR). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Transthoracic echo and esCCO stroke volume
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2015
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All consenting pregnant women above 18 years of age.
Who cannot join
- Women not consenting or unable to consent.
- Unwilling to remove nail varnish/false nails
- Peripheral circulatory problems eg Raynauds syndrome
- Unable to establish good plethysmography trace
- Medical conditions known to alter plethysmography eg hyperbiliruninaemia
About this study
Cardiac output (CO) is the volume of blood ejected from the heart and is a product of stroke volume (SV) vs heart rate (HR). It is closely related to Blood Pressure (BP) by the formula CO = Mean Arterial Pressure (MAP) / Systemic Vascular Resistance (SVR). Cardiac output monitoring is well established and validated for guiding fluid administration and resuscitation in intensive care and perioperatively in the non-pregnant population. Available CO monitoring methods may risk maternal health or fetal wellbeing or are unvalidated in the pregnant population. Invasive and semi-invasive methods of measuring CO such as the pulmonary artery catheter, the 'gold standard' require invasive arterial or central access negating their use in all but a select group of labouring women and have potentially serious risks attached to their usage. Echocardiography is a well-established and validated technique requiring no invasive access but the requirement for an experienced operator limits routine usage. It uses an external ultrasound probe to scan the heart.
Several novel non-invasive cardiac output monitors have recently come to the market including the estimated cardiac output esCCO monitor (Nihon Kohden) which uses Pulse Wave Transit Time (PWTT) to estimate cardiac output. It requires 3-lead Electrocardiography and pulse oximetry alone which is part of the routine monitoring for high risk patients on the labour ward.
The investigators research aims to evaluate the accuracy and precision of the esCCO in pregnant women and subsequently assess its utility during medical interventions such as epidural analgesia or caesarean section. The initial validation will take place in an antenatal clinic where women are assessed using Doppler echocardiography. The investigators will then compare the echocardiography results vs the esCCO results.
Read the detailed description
The cardiac output (CO) is the volume of blood ejected by the heart each time it beats. It is the product of stroke volume (SV) and heart rate (HR) and is expressed in litres per minute. It gives a measure of the performance of the heart as a pump. The normal resting CO of a 70kg person is approximately 5 to 6 litres/min, due to a resting HR of 70-80 bpm multiplied by an average SV of 70-80ml. Different organs in the body receive differing proportions of the CO according to their demand. CO increases significantly in pregnancy due to the growing uterus, fetus and placenta, and its actual value can be affected by patient position and medical interventions, such as epidural analgesia.
Cardiovascular changes in pregnancy
During pregnancy, the cardiovascular system changes to adapt to the demands of the uteroplacental unit. CO starts to increase from the first trimester by 35-40%, to a 50% rise by the end of the second trimester. It remains at this level during the third trimester 1. The increase in CO occurs due to an increase in HR by up to 25% and SV by up to 30%. There is a further rise in CO during labour and delivery, which is transient.
CO also depends upon patient position, with a 13.5% increase in the left lateral position from supine. The increase in CO in the left lateral position is the basis for the left lateral tilt or wedge applied to the pregnant patient when supine. This reduces compression of the large abdominal blood vessels (aortocaval compression) by the gravid (pregnant) uterus and allows the CO to be maintained.
The proportion of the CO distributed to the uterus, kidneys and skin is greater in pregnancy compared to the non-pregnant state. Uterine blood flow is approximately 500 to 700 ml/min, which corresponds to 10-12% of the CO 1. More than 80% of this CO perfuses the placenta.
Lumbar epidurals in labour
Lumbar epidurals are used commonly for analgesia in labour, as well as for anaesthesia for operative interventions, such as lower segment Caesarean section (LSCS) and instrumental delivery. It is well known that epidural anaesthesia can cause haemodynamic changes, namely peripheral vasodilatation and a reduction in systemic vascular resistance (SVR) due to blockade of the sympathetic nervous system which controls many autonomic functions including blood pressure and heart rate 1. This can lead to a reduction in blood pressure if the CO is maintained, since the three are related by the formula; mean arterial pressure (MAP) = CO x SVR. If the CO drops, for example due to hypovolaemia (decreased amount of fluid in the circulation) or postural changes, then there will be a greater decrease in the blood pressure.
Valsalva manoeuvre Originally described in the 17th century, the Valsalva manoeuvre is performed by attempted exhalation against resistance, usually a closed airway. It is used routinely to equalize ambient pressure in the inner ear and sinuses ie during air travel or scuba diving. Medically it is used as a test of cardiac function and the autonomic nervous system which controls the hearts response to stimuli.
The standardised Valsalva manoeuvre requires a subject to be placed in a semirecumbent position and produce an expiratory pressure of 40mmHg for 10 seconds2.
Methods for measuring cardiac output There are several methods for measuring cardiac output, but their use in pregnancy may be limited by risks to mother or the effects of the technique on the developing fetus.
Invasive methods - The "gold standard" CO monitor is the pulmonary artery catheter. This measures CO using the temperature change of an injectate (the thermodilution principle) as blood is passing through the cardiac chambers. It is accurate and allows measurement of pulmonary artery pressures, but the obvious drawback is the invasive nature of the device, coupled with the risks of injury to the heart and pulmonary vessels. Due to its invasive nature, this is used almost exclusively in patients who are severely unwell, necessitating central catheterisation. Even so, there is currently no evidence from randomised controlled trials supporting the use of the pulmonary artery catheters 2. Its use is not possible in normal pregnancies, as it would be unacceptable to subject patients to the risks of central catheterisation. Other invasive techniques such as angiography or conductance catheters cause radiation exposure to the developing fetus.
Semi-invasive methods include LiDCO and PiCCO. The LiDCO monitor uses transpulmonary lithium dilution via a central line catheter and arterial sampling line for calibration. It then uses arterial waveform analysis to provide continuous CO measurements. PiCCO uses transpulmonary thermodilution, again via a central line and arterial sampling line. The disadvantages of these are that lithium dilution should be avoided in the first trimester and normal pregnancies do not require central or arterial lines. This negates their use in the normal pregnant population. However, newer LiDCO products such as the LiDCOrapid have been used in the literature 3.
Non-invasive methods for cardiac output measurement have been the cornerstone of studying maternal cardiac physiology in normal and pathological pregnancies in the last 20 years, since the introduction of Doppler echocardiography, around 1985 4. Echocardiographic techniques aim to estimate the SV, which can then be multiplied by the HR to obtain a CO value. This can be done using 2D, 3D or Doppler echocardiography 5. The obvious advantage is that no vascular access or calibration is needed, but an experienced operator is required, making routine use difficult.
Novel non-invasive cardiac output monitors have since appeared on the market, such as the noninvasive cardiac output monitor (NICOM), the ultrasonic cardiac output monitor (USCOM) and the estimated continuous cardiac output (esCCO) monitor.
The esCCO monitor The esCCO monitor is manufactured by Nihon Kohden6 and uses 3 lead electrocardiogram and a pulse oximeter (oxygen saturation probe) to estimate CO.
This method of measuring CO was shown to correlate well with the trend of CO measured using the pulmonary artery catheterisation method7, 8. It has also been shown to correlate well with the echo Doppler during exercise9. Bataille et al (2012) compared the esCCO monitor with transthoracic echocardiography for CO measurement in intensive care patients10. The authors deemed the esCCO to be clinically unacceptable in critically ill patients, although there were questions about the validity of this study11, 12. This is primarily because of extensive vasoconstriction and peripheral shut down with the critically ill septic patients. Use of this device in obstetrics is acceptable.
The esCCO monitor uses non-invasive blood pressure (NIBP), three-lead ECG and pulse oximetry (SpO2). These modalities are part of routine clinical monitoring, which makes this monitor ideal for measuring CO in the normal pregnant population. Patients admitted to the labour ward often require monitoring with at least NIBP and SpO2, hence only the three-lead ECG is 'extra'. By validating this monitor, CO measurement across a variety of clinical scenarios in the pregnant population will be possible.
- Conditions
- Pregnancy
- Being tested
- Transthoracic echo and esCCO stroke volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echo and esCCO stroke volumeDevice
All participants will have their cardiac outputs measured using these two devices simultaneously. Cardiac output 1 will include measurements made using transthoracic echo and cardiac output 2 will be done using esCCO device.
| Study group | Role | What they receive |
|---|---|---|
| SV1, SV2 | Other | SV1 intervention: stroke volume using transthoracic echo SV2 intervention: stroke volume measured using the esCCO device. Receives: Device: Transthoracic echo and esCCO stroke volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of stroke volume using esCCO monitor and trans thoracic echo in pregnant women
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255448
- Sponsor's protocol ID
- 14/YH/1182
- Acronym
- esCCO
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the esCCO Non-invasive Cardiac Output Measurement Device in Pregnancy
- ClinicalTrials.gov ID
- NCT02255448
- Acronym / sponsor ID
- esCCO / 14/YH/1182
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 2 Oct 2014 (estimated)
- 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.
Cardiac output (CO) is the volume of blood ejected from the heart and is a product of stroke volume (SV) vs heart rate (HR). It is closely related to Blood Pressure (BP) by the formula CO = Mean Arterial Pressure (MAP) / Systemic Vascular Resistance (SVR). Cardiac output monitoring is well established and validated for guiding fluid administration and resuscitation in intensive care and perioperatively in the non-pregnant population. Available CO monitoring methods may risk maternal health or fetal wellbeing or are unvalidated in the pregnant population. Invasive and semi-invasive methods of measuring CO such as the pulmonary artery catheter, the 'gold standard' require invasive arterial or central access negating their use in all but a select group of labouring women and have potentially serious risks attached to their usage. Echocardiography is a well-established and validated technique requiring no invasive access but the requirement for an experienced operator limits routine usage. It uses an external ultrasound probe to scan the heart.
Several novel non-invasive cardiac output monitors have recently come to the market including the estimated cardiac output esCCO monitor (Nihon Kohden) which uses Pulse Wave Transit Time (PWTT) to estimate cardiac output. It requires 3-lead Electrocardiography and pulse oximetry alone which is part of the routine monitoring for high risk patients on the labour ward.
The investigators research aims to evaluate the accuracy and precision of the esCCO in pregnant women and subsequently assess its utility during medical interventions such as epidural analgesia or caesarean section. The initial validation will take place in an antenatal clinic where women are assessed using Doppler echocardiography. The investigators will then compare the echocardiography results vs the esCCO results.
Detailed description
The cardiac output (CO) is the volume of blood ejected by the heart each time it beats. It is the product of stroke volume (SV) and heart rate (HR) and is expressed in litres per minute. It gives a measure of the performance of the heart as a pump. The normal resting CO of a 70kg person is approximately 5 to 6 litres/min, due to a resting HR of 70-80 bpm multiplied by an average SV of 70-80ml. Different organs in the body receive differing proportions of the CO according to their demand. CO increases significantly in pregnancy due to the growing uterus, fetus and placenta, and its actual value can be affected by patient position and medical interventions, such as epidural analgesia.
Cardiovascular changes in pregnancy
During pregnancy, the cardiovascular system changes to adapt to the demands of the uteroplacental unit. CO starts to increase from the first trimester by 35-40%, to a 50% rise by the end of the second trimester. It remains at this level during the third trimester 1. The increase in CO occurs due to an increase in HR by up to 25% and SV by up to 30%. There is a further rise in CO during labour and delivery, which is transient.
CO also depends upon patient position, with a 13.5% increase in the left lateral position from supine. The increase in CO in the left lateral position is the basis for the left lateral tilt or wedge applied to the pregnant patient when supine. This reduces compression of the large abdominal blood vessels (aortocaval compression) by the gravid (pregnant) uterus and allows the CO to be maintained.
The proportion of the CO distributed to the uterus, kidneys and skin is greater in pregnancy compared to the non-pregnant state. Uterine blood flow is approximately 500 to 700 ml/min, which corresponds to 10-12% of the CO 1. More than 80% of this CO perfuses the placenta.
Lumbar epidurals in labour
Lumbar epidurals are used commonly for analgesia in labour, as well as for anaesthesia for operative interventions, such as lower segment Caesarean section (LSCS) and instrumental delivery. It is well known that epidural anaesthesia can cause haemodynamic changes, namely peripheral vasodilatation and a reduction in systemic vascular resistance (SVR) due to blockade of the sympathetic nervous system which controls many autonomic functions including blood pressure and heart rate 1. This can lead to a reduction in blood pressure if the CO is maintained, since the three are related by the formula; mean arterial pressure (MAP) = CO x SVR. If the CO drops, for example due to hypovolaemia (decreased amount of fluid in the circulation) or postural changes, then there will be a greater decrease in the blood pressure.
Valsalva manoeuvre Originally described in the 17th century, the Valsalva manoeuvre is performed by attempted exhalation against resistance, usually a closed airway. It is used routinely to equalize ambient pressure in the inner ear and sinuses ie during air travel or scuba diving. Medically it is used as a test of cardiac function and the autonomic nervous system which controls the hearts response to stimuli.
The standardised Valsalva manoeuvre requires a subject to be placed in a semirecumbent position and produce an expiratory pressure of 40mmHg for 10 seconds2.
Methods for measuring cardiac output There are several methods for measuring cardiac output, but their use in pregnancy may be limited by risks to mother or the effects of the technique on the developing fetus.
Invasive methods - The "gold standard" CO monitor is the pulmonary artery catheter. This measures CO using the temperature change of an injectate (the thermodilution principle) as blood is passing through the cardiac chambers. It is accurate and allows measurement of pulmonary artery pressures, but the obvious drawback is the invasive nature of the device, coupled with the risks of injury to the heart and pulmonary vessels. Due to its invasive nature, this is used almost exclusively in patients who are severely unwell, necessitating central catheterisation. Even so, there is currently no evidence from randomised controlled trials supporting the use of the pulmonary artery catheters 2. Its use is not possible in normal pregnancies, as it would be unacceptable to subject patients to the risks of central catheterisation. Other invasive techniques such as angiography or conductance catheters cause radiation exposure to the developing fetus.
Semi-invasive methods include LiDCO and PiCCO. The LiDCO monitor uses transpulmonary lithium dilution via a central line catheter and arterial sampling line for calibration. It then uses arterial waveform analysis to provide continuous CO measurements. PiCCO uses transpulmonary thermodilution, again via a central line and arterial sampling line. The disadvantages of these are that lithium dilution should be avoided in the first trimester and normal pregnancies do not require central or arterial lines. This negates their use in the normal pregnant population. However, newer LiDCO products such as the LiDCOrapid have been used in the literature 3.
Non-invasive methods for cardiac output measurement have been the cornerstone of studying maternal cardiac physiology in normal and pathological pregnancies in the last 20 years, since the introduction of Doppler echocardiography, around 1985 4. Echocardiographic techniques aim to estimate the SV, which can then be multiplied by the HR to obtain a CO value. This can be done using 2D, 3D or Doppler echocardiography 5. The obvious advantage is that no vascular access or calibration is needed, but an experienced operator is required, making routine use difficult.
Novel non-invasive cardiac output monitors have since appeared on the market, such as the noninvasive cardiac output monitor (NICOM), the ultrasonic cardiac output monitor (USCOM) and the estimated continuous cardiac output (esCCO) monitor.
The esCCO monitor The esCCO monitor is manufactured by Nihon Kohden6 and uses 3 lead electrocardiogram and a pulse oximeter (oxygen saturation probe) to estimate CO.
This method of measuring CO was shown to correlate well with the trend of CO measured using the pulmonary artery catheterisation method7, 8. It has also been shown to correlate well with the echo Doppler during exercise9. Bataille et al (2012) compared the esCCO monitor with transthoracic echocardiography for CO measurement in intensive care patients10. The authors deemed the esCCO to be clinically unacceptable in critically ill patients, although there were questions about the validity of this study11, 12. This is primarily because of extensive vasoconstriction and peripheral shut down with the critically ill septic patients. Use of this device in obstetrics is acceptable.
The esCCO monitor uses non-invasive blood pressure (NIBP), three-lead ECG and pulse oximetry (SpO2). These modalities are part of routine clinical monitoring, which makes this monitor ideal for measuring CO in the normal pregnant population. Patients admitted to the labour ward often require monitoring with at least NIBP and SpO2, hence only the three-lead ECG is 'extra'. By validating this monitor, CO measurement across a variety of clinical scenarios in the pregnant population will be possible.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SV1, SV2 | Other | Device: Transthoracic echo and esCCO stroke volumeSV1 intervention: stroke volume using transthoracic echo SV2 intervention: stroke volume measured using the esCCO device. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All consenting pregnant women above 18 years of age.
Key exclusion criteria (5 listed)
- Women not consenting or unable to consent.
- Unwilling to remove nail varnish/false nails
- Peripheral circulatory problems eg Raynauds syndrome
- Unable to establish good plethysmography trace
- Medical conditions known to alter plethysmography eg hyperbiliruninaemia
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 echo and esCCO stroke volumeAll participants will have their cardiac outputs measured using these two devices simultaneously. Cardiac output 1 will include measurements made using transthoracic echo and cardiac output 2 will be done using esCCO device. | Device | SV1, SV2 |
Primary outcome
Comparison of stroke volume using esCCO monitor and trans thoracic echo in pregnant women
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echo and esCCO stroke volume in people with Pregnancy, run by King's College Hospital NHS Trust.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Comparison of stroke volume using esCCO monitor and trans thoracic echo in pregnant women (time frame: 30 minutes). 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 3 Oct 2014; AzTrials last refreshed its copy on 8 Nov 2026.