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

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ClinicalTrials.gov Identifier: NCT02255448
Recruitment Status : Unknown
Verified September 2014 by King's College Hospital NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : October 2, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.


Condition or disease Intervention/treatment Phase
Pregnancy Device: Transthoracic echo and esCCO stroke volume Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Official Title: Evaluation of the esCCO Non-invasive Cardiac Output Measurement Device in Pregnancy
Study Start Date : November 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Arm Intervention/treatment
SV1, SV2
SV1 intervention: stroke volume using transthoracic echo SV2 intervention: stroke volume measured using the esCCO device.
Device: Transthoracic echo and esCCO stroke volume
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.




Primary Outcome Measures :
  1. Comparison of stroke volume using esCCO monitor and trans thoracic echo in pregnant women [ Time Frame: 30 minutes ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02255448     History of Changes
Other Study ID Numbers: 14/YH/1182
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: September 2014