Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 62 of 629 for:    oximeter

Evaluation of Compensatory Reserve in Obstetrical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 31, 2015
First Posted Date April 3, 2015
Last Update Posted Date April 18, 2019
Study Start Date February 2015
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2016)
Changes in Central Volume Status [ Time Frame: enrollment ]
Use pulse oximeter waveform data to determine central volume status changes
Original Primary Outcome Measures
 (submitted: April 2, 2015)
Central Volume Status Changes [ Time Frame: enrollment ]
Use pulse oximeter waveform data to determine central volume status changes
Change History Complete list of historical versions of study NCT02408588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Compensatory Reserve in Obstetrical Patients
Official Title Evaluation of Compensatory Reserve in Obstetrical Patients
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Parturition
  • Fetal Intervention
Intervention Other: Pulse oximeter
Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
Study Groups/Cohorts
  • Childbirth and epidural
    Pregnant women giving childbirth who receive an epidural.
    Intervention: Other: Pulse oximeter
  • Childbirth and general anesthesia
    Pregnant women giving childbirth who receive general anesthesia
    Intervention: Other: Pulse oximeter
  • Fetal Intervention and epidural
    Pregnant women receiving fetal intervention and an epidural
    Intervention: Other: Pulse oximeter
  • Fetal Intervention and general anesthesia
    Pregnant women receiving fetal intervention and general anesthesia
    Intervention: Other: Pulse oximeter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 12, 2017)
600
Original Estimated Enrollment
 (submitted: April 2, 2015)
200
Estimated Study Completion Date December 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages up to 44 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02408588
Other Study ID Numbers 14-1996
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Steven Moulton, MD Childrens Hospital Colorado
PRS Account University of Colorado, Denver
Verification Date April 2019