NCT00884026

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

April 3, 2009

Last Update Submit

January 22, 2013

Conditions

HypotensionCesarean Delivery

Keywords

Cesarean deliveryhypotensionAugmentation IndexPulse Wave analysisspinal anesthesiaHypotension following spinal anesthesia for cesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Occurrence of hypotension following spinal anesthesia. Defined as systolic BP > 20% from baseline.

    1 week

Secondary Outcomes (1)

  • Augmentation Index as measured by the SphygmacorTM preoperatively; Bradycardia requiring pharmacological treatment; Ephedrine requirement; Phenylephrine requirement; Block Height; Nausea/vomiting

    1 week

Study Arms (2)

1

ACTIVE COMPARATOR

Subjects that experience hypotension after spinal anesthesia.

Device: AIx measurement with a Sphygmacor TM

2

ACTIVE COMPARATOR

Subjects that do not experience hypotension after spinal anesthesia.

Device: AIx measurement with a Sphygmacor TM

Interventions

AIx measurement with a Sphygmacor TMDEVICE

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.

1

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All women undergoing elective or urgent cesarean delivery under spinal anesthesia
  • Singleton Pregnancy
  • Greater than 37 weeks gestation
  • Healthy subjects with ASA 1 \& 2 classification of health
  • Potential subjects need to be able to read and understand English unless independent (non-partner) translator available

You may not qualify if:

  • ASA 3 or above
  • Emergency cesarean delivery for fetal heart rate abnormalities
  • Cesarean delivery under general, epidural, or combined spinal epidural anesthesia
  • Maternal age \<19 years
  • Maternal infection
  • Mothers with vascular disease - including hypertension/pre-eclampsia
  • Mothers with Diabetes Mellitus
  • Polyhdramnios
  • Multiple Pregnancy
  • Height \< 150cm or \> 180cm
  • BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital Dept of Anesthesia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Vit Gunka, MD, FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • James Shannon, FCARSCI MSc

    University of British Columbia

    STUDY DIRECTOR

  • Joanne Douglas, MD, FRCPC

    University of British Columbia

    STUDY DIRECTOR

  • Jessica Tyler, BSc

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 20, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

CA(1)