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Clinical Trials/NCT02255448
NCT02255448UnknownNot Applicable

Evaluation of the esCCO Non-invasive Cardiac Output Measurement Device in Pregnancy

King's College Hospital NHS Trust0 sites100 target enrollmentStarted: November 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Primary Endpoint
Comparison of stroke volume using esCCO monitor and trans thoracic echo in pregnant women

Study Overview

Brief 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). 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All consenting pregnant women above 18 years of age.

Exclusion Criteria

  • •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

Arms & Interventions

SV1, SV2

Other

SV1 intervention: stroke volume using transthoracic echo SV2 intervention: stroke volume measured using the esCCO device.

Intervention: Transthoracic echo and esCCO stroke volume (Device)

Outcomes

Primary Outcomes

Comparison of stroke volume using esCCO monitor and trans thoracic echo in pregnant women

Time Frame: 30 minutes

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
King's College Hospital NHS Trust
Sponsor Class
Other
Responsible Party
Sponsor

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