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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01699243
Collaborator
(none)
19
Enrollment
2
Locations
141
Duration (Months)
9.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Specific aims:

    1. 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.

    2. 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.

    3. 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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    19 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Continuous, Noninvasive Method for Estimating and Predicting Maternal and Fetal Hemodynamic Changes During Regional Anesthesia
    Study Start Date :
    Sep 1, 2012
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Epidural

    subjects under epidural anesthesia

    Outcome Measures

    Primary Outcome Measures

    1. effective intravascular volume loss during maternal regional anesthesia [during epidural, 1-4 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Age: 14 - 44 years
      1. Pregnant
      1. 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
      1. Pre-procedural maternal hypertension requiring treatment
      1. Significant fetal heart rate abnormalities prior to regional anesthesia
      1. Incarcerated
      1. Decisionally challenged
      1. Limited access to or compromised monitoring sites for non-invasive finger and ear or forehead sensors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Colorado Aurora Colorado United States 80045
    2 University of Colorado Hospital Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Steve Moulton, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT01699243
    Other Study ID Numbers:
    • 12-0990
    First Posted:
    Oct 3, 2012
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by University of Colorado, Denver
    pregnancy
    labor
    epidural
    fetal intervention

    Study Results

    No Results Posted as of Aug 17, 2022