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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01699243
First received: October 1, 2012
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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. We hypothesize that these same methods can be used to predict functional hypovolemia during regional anesthesia for labor or fetal intervention.


Condition
Pregnancy
Anesthesia

Study Type: Observational
Study Design: 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

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • effective intravascular volume loss during maternal regional anesthesia [ Time Frame: during epidural, 1-4 hours ] [ Designated as safety issue: No ]
    Develop algorithm for estimating effective intravascular volume loss during maternal regional anesthesia


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epidural
subjects under epidural anesthesia

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
  Eligibility

Ages Eligible for Study:   14 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All pregnant females undergoing regional anesthesia for labor or fetal intervention at the University of Colorado Hospital and Children's Hospital Colorado.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699243

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
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
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01699243     History of Changes
Other Study ID Numbers: 12-0990
Study First Received: October 1, 2012
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
pregnancy
labor
epidural
fetal intervention

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014