PVI for Prediction of Spinal Induced Hypotension

Completed

• Conditions: Spinal Induced Hypotension
• Interventions: Other: PVI

• Registration Number: NCT01967914
• Lead Sponsor: Duke University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing cesarean delivery under spinal anesthesia	PVI	-

Primary Outcome Measures

Name	Time	Method
Correlation between baseline PVI and change in SBP from baseline.	Intraoperative (approximately 2 hours)	Correlation between baseline PVI and change in SBP from baseline.

Secondary Outcome Measures

Name	Time	Method
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	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.	Intraoperative (approximately 2 hours)
Correlation between baseline PVI and need for vasopressors.	Intraoperative (approximately 2 hours)
Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors	Intraoperative (approximately 2 hours)
Correlation between baseline PVI and change in SBP and PR from baseline.	Intraoperative (approximately 2 hours)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States