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

Anesthesia 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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Pregnancy

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