Can Augmentation Index (AIx) be Used to Predict Hypotension After Spinal Anesthesia?
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | April 3, 2009 | ||||||||||||||||
| Last Updated Date | January 22, 2013 | ||||||||||||||||
| Start Date ICMJE | March 2009 | ||||||||||||||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Occurrence of hypotension following spinal anesthesia. Defined as systolic BP > 20% from baseline. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00884026 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Augmentation Index as measured by the SphygmacorTM preoperatively; Bradycardia requiring pharmacological treatment; Ephedrine requirement; Phenylephrine requirement; Block Height; Nausea/vomiting [ Time Frame: 1 week ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Can Augmentation Index (AIx) be Used to Predict Hypotension After Spinal Anesthesia? | ||||||||||||||||
| Official Title ICMJE | Pulse Wave Analysis and Augmentation Index Changes Associated With Neuraxial Anesthesia in the Parturient | ||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 56 | ||||||||||||||||
| Completion Date | March 2010 | ||||||||||||||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||||||
| Ages | 19 Years to 45 Years | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00884026 | ||||||||||||||||
| Other Study ID Numbers ICMJE | H08-03019 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | University of British Columbia | ||||||||||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||||||||||
| Collaborators ICMJE | Children's & Women's Health Centre of British Columbia | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||||||||||
| Verification Date | January 2013 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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