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NCT02408588 Clinical Trial

Evaluation of Compensatory Reserve in Obstetrical Patients

Parturition Clinical Trial

Official title:
Evaluation of Compensatory Reserve in Obstetrical Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02408588
Other study ID # 14-1996
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 1, 2015
Est. completion date May 2024

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

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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 600
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Female
Age group 0 Days to 44 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Pulse oximeter
Place a pulse oximeter on the subject which will record the pulse oximeter waveform.

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Central Volume Status Use pulse oximeter waveform data to determine central volume status changes enrollment
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