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PVI for Prediction of Spinal Induced Hypotension

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ClinicalTrials.gov Identifier: NCT01967914
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery

Condition or disease Intervention/treatment
Spinal Induced Hypotension Other: PVI

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Group/Cohort Intervention/treatment
Women undergoing cesarean delivery under spinal anesthesia Other: PVI
Measurement of PVI (plethysmography variability index)




Primary Outcome Measures :
  1. Correlation between baseline PVI and change in SBP from baseline. [ Time Frame: Intraoperative (approximately 2 hours) ]
    Correlation between baseline PVI and change in SBP from baseline.


Secondary Outcome Measures :
  1. Correlation between plethysmography variability index (PVI) change in response to passive leg raising (PLR) and change in SBP and pulse rate (PR) from baseline, and need for vasopressors [ Time Frame: Intraoperative (approximately 2 hours) ]
    Correlation between PVI change in response to PLR and change in SBP and pulse rate (PR) from baseline, and need for vasopressors

  2. Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors. [ Time Frame: Intraoperative (approximately 2 hours) ]
  3. Correlation between baseline PVI and need for vasopressors. [ Time Frame: Intraoperative (approximately 2 hours) ]
  4. Correlation between baseline PVI and change in SBP and PR from baseline. [ Time Frame: Intraoperative (approximately 2 hours) ]
  5. Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors [ Time Frame: Intraoperative (approximately 2 hours) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing cesarean delivery under spinal anesthesia
Criteria

Inclusion Criteria:

  • English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
  • Scheduled or unscheduled cesarean delivery under spinal anesthesia
  • Height: 5 feet-5 feet 11 in.

Exclusion Criteria:

  • Laboring women needing an emergency cesarean delivery
  • Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
  • Severe Cardiac disease in pregnancy with marked functional limitations
  • Diabetes type I
  • Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
  • Inclusion in another anesthetic study involving drug administration.

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): NCT01967914


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Ashraf S Habib, MB Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01967914     History of Changes
Other Study ID Numbers: Pro00046443
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases