This trial is active, not recruiting.

Conditions pregnancy, anesthesia
Sponsor University of Colorado, Denver
Start date September 2012
End date December 2016
Trial size 200 participants
Trial identifier NCT01699243, 12-0990


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
subjects under epidural anesthesia

Primary Outcomes

effective intravascular volume loss during maternal regional anesthesia
time frame: during epidural, 1-4 hours

Eligibility Criteria

Female participants from 14 years up to 44 years old.

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

Additional Information

Official title A Continuous, Noninvasive Method for Estimating and Predicting Maternal and Fetal Hemodynamic Changes During Regional Anesthesia
Principal investigator Steve Moulton, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.