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

NCT02255448 | Unknown

• 1 other identifier: 14/YH/1182
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

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

  30 minutes

Study Arms (1)

SV1, SV2

OTHER

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

Device: Transthoracic echo and esCCO stroke volume

Interventions

Transthoracic echo and esCCO stroke volume DEVICE

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.

SV1, SV2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All consenting pregnant women above 18 years of age.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 2, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 3, 2014

Record last verified: 2014-09