Evaluation of Compensatory Reserve in Obstetrical Patients
NCT ID: NCT02408588
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2015-02-01
2024-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Childbirth and epidural
Pregnant women giving childbirth who receive an epidural.
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
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
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
Pulse oximeter
Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
Interventions
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Pulse oximeter
Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
Eligibility Criteria
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Inclusion Criteria
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
2. Decisionally challenged
3. Patients who object at any time to participating in the study
0 Days
44 Years
FEMALE
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Steven Moulton, MD
Role: PRINCIPAL_INVESTIGATOR
Childrens Hospital Colorado
Other Identifiers
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14-1996
Identifier Type: -
Identifier Source: org_study_id
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