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OpenTrials
Completed

NCT Number: NCT01699243

Continuous Noninvasive Method for Estimating and Predicting Maternal and Fetal Hemodynamic Changes During Regional Anesthesia

Machine learning techniques and algorithms originally developed for use in the field of robotics can be applied to continuous, noninvasive physiological waveform data to discover hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) predict cardiovascular collapse well ahead of any clinically significant changes in standard vital signs, 2) monitor and estimate fluid resuscitation needs, 3) estimate acute blood loss volume, and 4) estimate intracranial pressure. The investigators hypothesize that these same methods can be used to predict functional hypovolemia during regional anesthesia for labor or fetal intervention.

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Key information

Conditions

Age range

14 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

Specific aims:

  • Collect noninvasive physiological waveform data from patients undergoing regional anesthesia for labor or fetal intervention at the University of Colorado Hospital and Children's Hospital Colorado.
  • Combine the physiological data from patient monitors with clinical and demographic data, including maternal problem list, medications, volume infused, use of vasopressors, arterial and venous pressures, fetal heart rate, fetal umbilical artery Doppler velocimetry, maternal uterine artery Doppler waveform, fetal and neonatal outcomes etc. for use in developing mathematical model for early detection of maternal functional hypovolemia.
  • Develop robust, real-time, computational models for:
  • estimating maternal volume status prior to administration of epidural anesthesia
  • estimating effective intravascular volume loss during maternal regional anesthesia
  • predicting an optimal, individual specific requirement for IV resuscitation and/or need for vasopressor agents while providing adequate analgesia using regional techniques and optimizing the fetal outcomes
  • identifying mothers susceptible to epidural induced hypotension

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age: 14 - 44 years
  • 2. Pregnant
  • 3. Undergoing regional anesthesia for labor or fetal intervention at the University of Colorado Hospital and Children's Hospital Colorado

Exclusion criteria

  • 1. Severe pre-eclampsia/eclampsia
  • 2. Pre-procedural maternal hypertension requiring treatment
  • 3. Significant fetal heart rate abnormalities prior to regional anesthesia
  • 4. Incarcerated
  • 5. Decisionally challenged
  • 6. Limited access to or compromised monitoring sites for non-invasive finger and ear or forehead sensors

Treatment and study plan

Primary outcomes

  1. effective intravascular volume loss during maternal regional anesthesia

    Time frame: during epidural, 1-4 hours

    Develop algorithm for estimating effective intravascular volume loss during maternal regional anesthesia

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

A Continuous, Noninvasive Method for Estimating and Predicting Maternal and Fetal Hemodynamic Changes During Regional Anesthesia

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2012
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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