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NCT01699243 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01699243
Other study ID # 12-0990
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2012
Est. completion date June 1, 2016

Study information
Verified date September 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date June 1, 2016
Est. primary completion date June 1, 2016
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 44 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Colorado Aurora Colorado
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary effective intravascular volume loss during maternal regional anesthesia Develop algorithm for estimating effective intravascular volume loss during maternal regional anesthesia during epidural, 1-4 hours
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