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Evaluation of Compensatory Reserve in Obstetrical Patients

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ClinicalTrials.gov Identifier: NCT02408588
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2015
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment
Parturition Fetal Intervention 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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Compensatory Reserve in Obstetrical Patients
Study Start Date : February 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

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.




Primary Outcome Measures :
  1. Changes in Central Volume Status [ Time Frame: enrollment ]
    Use pulse oximeter waveform data to determine central volume status changes



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Ages Eligible for Study:   up to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408588


Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Steven Moulton, MD Childrens Hospital Colorado

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02408588     History of Changes
Other Study ID Numbers: 14-1996
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs