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Can Augmentation Index (AIx) be Used to Predict Hypotension After Spinal Anesthesia?

NCT00884026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2013-01-23

No results posted yet for this study

Summary

A fall in blood pressure (hypotension) occurs in one third of spinal anesthetics administered to pregnant patients undergoing cesarean delivery. However, predicting which patients will experience hypotension following spinal anesthesia has proven difficult. Pulse wave analysis is a repeatable and reproducible method for investigation of cardiovascular function. A device called a SphygmacorTM can be used to measure pulse. The pulse measurement is called the Augmentation Index (AIx). AIx has been useful in detecting risks associated with blood pressure changes after complex surgery in patients with heart and blood vessel disease. In this study the investigators wish to see if it is possible to predict if a subject will experience hypotension based on her AIx measurement preoperatively.

Conditions

Interventions

DEVICE

AIx measurement with a Sphygmacor TM

All subjects will have their AIx measured prior to surgery. After 30 subjects are recruited, they will be split into 2 groups. Group 1 will be those subjects who developed hypotension, and Group 2 will be those subjects who did not develop hypotension. We will then look at the preoperative measured AIx to determine whether there is a baseline difference between the two groups. A threshold value of the AIx with the best sensitivity and specificity for prediction of hypotension will then be determined.

DEVICE

AIx measurement with a Sphygmacor TM

The second part of the study will then use the threshold AIx value found from the subjects who developed hypotension from the first 30 subjects to prospectively predict hypotension after spinal anesthesia in another 60 subjects

Sponsors & Collaborators

  • Children's & Women's Health Centre of British Columbia

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Vit Gunka, MD, FRCPC · University of British Columbia

  • James Shannon, FCARSCI MSc · University of British Columbia

  • Joanne Douglas, MD, FRCPC · University of British Columbia

  • Jessica Tyler, BSc · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00884026 on ClinicalTrials.gov