Evaluation of Compensatory Reserve in Obstetrical Patients

Using a pulse oximeter, the investigators have developed an algorithm that assesses central volume status. Pregnant women present some unique opportunities for us to investigate the algorithm under different circumstances. The investigators want to specifically investigate an algorithm with women who undergo regional anesthesia such as epidurals, with women who undergo fetal surgery, and with women in labor and giving birth (and the recovery time following delivery). This will help the investigators understand the central volume status changes that women experience in these unique circumstances. The Investigators also want to put the pulse oximeter on the fetal hand when possible during certain maternal fetal interventions. The Investigators would like to examine the algorithm with data from the fetuses.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parturition; Fetal Intervention
• Intervention / Treatment: Other: Pulse oximeter

Detailed Description

The Investigators hypothesize that the Compensatory Reserve Index (CRI) algorithm will help to guide fluid management in women undergoing regional anesthesia, giving birth, and/or undergoing maternal fetal intervention surgery.

Specific aims:

Collect noninvasive physiological waveform data from patients undergoing regional anesthesia and either fetal intervention surgery or labor and delivery at Children's Hospital Colorado in order to:

1. Determine how regional anesthesia influences CRI algorithm calculations
2. Determine if the CRI algorithm is able to detect changes in central volume status associated with fetal surgery.
3. Determine if the CRI algorithm is able to detect changes in central volume status associated with labor and childbirth specifically at the time of delivery, when most women experience some amount of bleeding.
4. Examine CRI associated with induction of regional anesthesia and determine if there is a minimal CRI below which one can expect hypotension and if there is a trend down in CRI following induction of regional anesthesia that could anticipate/predict hypotension.
5. Determine if there is a correlation between fetal heart rate abnormalities and CRI.
6. Examine CRI associated with fetal monitoring.

• Study Type: Observational
• Enrollment (Estimated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Enrollment is limited to pregnant females because only pregnant females undergo fetal surgery and/or labor and childbirth.

Description

Inclusion Criteria:

1. Age: 14 years - 44 years or 0 day old neonates born during the protocol
2. Pregnant
3. Patients undergoing regional anesthesia and either fetal intervention surgery or labor at Children's Hospital Colorado (CHCO) or University of Colorado Hospital (UCH)

Exclusion Criteria:

1. Incarcerated
2. Decisionally challenged
3. Patients who object at any time to participating in the study

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Childbirth and epidural; Pregnant women giving childbirth who receive an epidural.	Other: Pulse oximeter; Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
Childbirth and general anesthesia; Pregnant women giving childbirth who receive general anesthesia	Other: Pulse oximeter; Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
Fetal Intervention and epidural; Pregnant women receiving fetal intervention and an epidural	Other: Pulse oximeter; Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
Fetal Intervention and general anesthesia; Pregnant women receiving fetal intervention and general anesthesia	Other: Pulse oximeter; Place a pulse oximeter on the subject which will record the pulse oximeter waveform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Central Volume Status	Use pulse oximeter waveform data to determine central volume status changes	enrollment

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Steven Moulton, MD, Childrens Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimated): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 14-1996