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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

Tracking Information
First Submitted Date October 17, 2013
First Posted Date October 23, 2013
Last Update Posted Date June 17, 2015
Study Start Date October 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01967914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 15, 2015)
  • 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
  • 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) ]
  • Correlation between baseline PVI and need for vasopressors. [ Time Frame: Intraoperative (approximately 2 hours) ]
  • Correlation between baseline PVI and change in SBP and PR from baseline. [ Time Frame: Intraoperative (approximately 2 hours) ]
  • 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) ]
Original Secondary Outcome Measures
 (submitted: October 18, 2013)
  • Correlation between PVI change in response to 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
  • 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) ]
  • Correlation between baseline PVI and need for vasopressors. [ Time Frame: Intraoperative (approximately 2 hours) ]
  • Correlation between baseline PVI and change in SBP and PR from baseline. [ Time Frame: Intraoperative (approximately 2 hours) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PVI for Prediction of Spinal Induced Hypotension
Official Title Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?
Brief Summary The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery
Detailed Description Not Provided
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 Women undergoing cesarean delivery under spinal anesthesia
Condition Spinal Induced Hypotension
Intervention Other: PVI
Measurement of PVI (plethysmography variability index)
Study Groups/Cohorts Women undergoing cesarean delivery under spinal anesthesia
Intervention: Other: PVI
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 Completed
Actual Enrollment
 (submitted: June 15, 2015)
38
Original Estimated Enrollment
 (submitted: October 18, 2013)
40
Actual Study Completion Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01967914
Other Study ID Numbers Pro00046443
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Ashraf S Habib, MB Duke University
PRS Account Duke University
Verification Date June 2015