Can Augmentation Index (AIx) be Used to Predict Hypotension After Spinal Anesthesia?
Primary Purpose
Hypotension, Cesarean Delivery
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
AIx measurement with a Sphygmacor TM
AIx measurement with a Sphygmacor TM
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension focused on measuring Cesarean delivery, hypotension, Augmentation Index, Pulse Wave analysis, spinal anesthesia, Hypotension following spinal anesthesia for cesarean delivery
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- BC Women's Hospital Dept of Anesthesia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Subjects that experience hypotension after spinal anesthesia.
Subjects that do not experience hypotension after spinal anesthesia.
Outcomes
Primary Outcome Measures
Occurrence of hypotension following spinal anesthesia. Defined as systolic BP > 20% from baseline.
Secondary Outcome Measures
Augmentation Index as measured by the SphygmacorTM preoperatively; Bradycardia requiring pharmacological treatment; Ephedrine requirement; Phenylephrine requirement; Block Height; Nausea/vomiting
Full Information
NCT ID
NCT00884026
First Posted
April 3, 2009
Last Updated
January 22, 2013
Sponsor
University of British Columbia
Collaborators
Children's & Women's Health Centre of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00884026
Brief Title
Can Augmentation Index (AIx) be Used to Predict Hypotension After Spinal Anesthesia?
Official Title
Pulse Wave Analysis and Augmentation Index Changes Associated With Neuraxial Anesthesia in the Parturient
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Children's & Women's Health Centre of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
At BC Women's Hospital (BCWH), anesthesiologists give spinal anesthesia for most elective cesarean deliveries. When the spinal medication is given, blood vessels expand in reaction to the spinal medication causing blood pressure to fall. If a patient experiences this common reaction, the anesthesiologist would administer some medications to restore blood pressure to normal. They do this to protect the blood supply to the placenta and to the baby.
It is not known why this happens in some people and not in others. The way blood circulates through the body can provide information about changes occurring in the body. Pulse measurements are a simple way of providing physicians with important clinical information about patient health.
A device called a SphygmacorTM can be used to measure a 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 our study we wish to see if AIx can predict a normal patient's risk of hypotension after spinal anesthesia. If a trend between AIx and the onset of hypotension after spinal anesthesia can be found, anesthesiologists can more effectively prevent and treat hypotension by being able to predict whether it will occur.
Consenting subjects will have their blood pressure and AIx measurement taken prior to surgery.
Surgery will commence as per usual practice at BCWH. If hypotension occurs after the spinal anesthesia, anesthesiologist will treat as per usual practice.
Following recruitment and data collection on the first 30 subjects we will review their anesthetic records to assess whether they became hypotensive or not (systolic BP > 20% from baseline). This will give us two 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Cesarean Delivery
Keywords
Cesarean delivery, hypotension, Augmentation Index, Pulse Wave analysis, spinal anesthesia, Hypotension following spinal anesthesia for cesarean delivery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Subjects that experience hypotension after spinal anesthesia.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Subjects that do not experience hypotension after spinal anesthesia.
Intervention Type
Device
Intervention Name(s)
AIx measurement with a Sphygmacor TM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AIx measurement with a Sphygmacor TM
Intervention Description
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
Primary Outcome Measure Information:
Title
Occurrence of hypotension following spinal anesthesia. Defined as systolic BP > 20% from baseline.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Augmentation Index as measured by the SphygmacorTM preoperatively; Bradycardia requiring pharmacological treatment; Ephedrine requirement; Phenylephrine requirement; Block Height; Nausea/vomiting
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vit Gunka, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Shannon, FCARSCI MSc
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanne Douglas, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jessica Tyler, BSc
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
BC Women's Hospital Dept of Anesthesia
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
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Can Augmentation Index (AIx) be Used to Predict Hypotension After Spinal Anesthesia?
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