HypotensionNCT01279889
Predicting Hypotension Related to Spinal Anesthesia
An observational study of Hypotension, run by University of British Columbia at 1 site in Canada.
Trial summary
This study aims to identify women at risk of low blood pressure (hypotension) after the usual cesarean anesthetic - a spinal anesthetic. Hypotension may be caused by dehydration. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women who are admitted to the hospital for a scheduled elective cesarean delivery
Who may be able to join
- Height less than 150cm or greater than 180cm
- Body Mass Index (BMI) greater than 40kg/m2: obesity makes accurate non-invasive blood pressure (BP) measurement difficult. It may also affect speed of onset and height of subarachnoid block due to increased epidural venous plexus engorgement and thecal sac compression resulting in more marked hypotension.
- Pregnancy induced hypertension (BP after 20wk greater than 140/90 with proteinuria)
- High risk of hemorrhage - where fluid volume expansion is planned prior to delivery (e.g. placenta previa, placenta accreta)
Who cannot join
- Starting BP is less than 100 systolic: as the lower limit for intervention defined in this study is 90sys which will likely be within the error of the BP measurement device
- There is a prolonged (more than 2 hour) wait between testing and spinal insertion: as patients may become more dehydrated affecting hypotension rates
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Women's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Predicting Hypotension Resistant to Phenylephrine (PE) Infusion in Elective Cesarean Delivery (CD)
This study aims to identify women at risk of low blood pressure (hypotension) after the usual cesarean anesthetic - a spinal anesthetic. Hypotension may be caused by dehydration. We believe we can predict who will get hypotension by using two anesthesia monitors together with a passive leg raise (PLR) (legs elevated after a period spent reclining). The PLR will cause a shift of blood from the legs to the heart, and the monitors will detect the heart's response to tell if a subject is dehydrated. We want to see if these dehydration tests can also predict hypotension after a spinal anesthetic.
Read the detailed description
We aim to predict the development of spinal anesthesia related hypotension in subjects already receiving a prophylactic infusion of phenylephrine (PE) who are having a cesarean delivery (CD). Hypotension arising in this fashion may signify that a subject is actually relatively fluid-deplete, and might benefit from intravenous (IV) fluid replacement. We will observe the association between hypotension and results of pre-anesthesia tests with two non-invasive monitors used in conjunction with a dynamic cardiovascular fluid challenge (by using a passive leg raise (PLR) maneuver). The use of any therapeutic intervention such as a fluid infusion would be the object of a subsequent study.
We propose that a minority of parturients present for elective CD being relatively fluid deplete. It is our hypothesis that the characteristics of passive leg raise (PLR) induced changes in the plethysmography variability index (PVI generated by the Masimo Radical 7™) and cardiac output (CO as derived from the Non Invasive Cardiac Output Monitor (NICOM) produced by Cheetah Medical™) will identify these subjects and that without large volume fluid administration they are likely to develop hypotension despite the use of a prophylactic PE infusion
Justification: Hypotension is the most common cause of spinal anesthesia related morbidity in cesarean delivery. Hypotension is very common and without treatment can affect over 80% of women. The mechanism is usually twofold: Firstly preload to the right ventricle (RV) is reduced as a result of venodilation from spinal sympathetic blockade. Unfortunately attempting to improve preload by infusion of IV fluid alone doesn't make much difference to the rates of hypotension (only 16% reduction in one large study). The second mechanism results from afterload reduction through arterial vasodilation which directly causes a reduction in blood pressure (BP). The treatment for this is most commonly a PE infusion, and when used this makes a significant difference reducing rates by over 50%. Unfortunately again there are a few who don't seem to respond (the residual of hypotension remains about 30%). Increasing the doses of PE only increases the rate of side effects, without affecting hypotension rates. However, giving both fluid and a PE infusion does seem to prevent hypotension in almost all subjects, suggesting that those who were resistant to PE alone actually did need some fluid. These subjects however are the exception not the rule, and giving fluid to these relatively "fluid deplete" as well as the rest may result in an increase in fluid related side effects. We believe that fluid therapy could be tailored better if we could identify which subjects are actually fluid deplete in the first instance.
Testing to predict fluid responsiveness has been studied in the intensive care unit (ICU) but not in obstetric subjects. Using a PLR increases the return of blood to the right ventricle (RV). In a fluid deplete individual this significantly improves venous return such that CO changes dramatically. In a well hydrated individual venous return is already adequate so the change in CO is less. The NICOM will directly detect the CO change induced by a PLR. The Masimo detects variations in the pulse oximetry plethysmograph trace that result from subtle variations in the cardiac output caused by changes in the intrathoracic pressure from breathing. Intrathoracic pressure increases during expiration in a spontaneously breathing subject and causes a reduction in venous return to the RV which causes a subsequent fall in CO. The variation in the plethysmography signal with respiration is displayed as a percentage index of the baseline signal strength which correlates with how much venous return to the RV is affected by respiration. If a subject's preload is low the plethysmography variability index (PVI) will be high from the dramatic fluctuation in CO with changes in intrathoracic pressure. Unfortunately with spontaneously breathing subjects this value is not consistent enough between individuals for PVI itself to give an accurate indication of fluid volume state. However changes induced in the PVI within an individual subject from a challenge such as fluid infusion or a PLR appear to be better at indicating fluid responsiveness.
We plan to use both the NICOM and the Masimo in conjunction with a PLR to assess fluid state (deplete or otherwise) preoperatively. We will then observe whether or not the pre-anesthesia testing correlates with development of PE infusion resistant hypotension during the routine spinal anesthetic.
The primary objective of this study is to correlate the results of pre-anesthesia testing with actual development of PE infusion resistant hypotension. Secondary outcomes are discussed in statistical analysis below.
- Conditions
- Hypotension
- Keywords
- hypotension, cesarean delivery, cardiac output, blood pressure, plethysmography variability index
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Delivery | Healthy pregnant women having an elective cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive leg raise related cardiac output change and correlation with presence of phenylephrine infusion resistant hypotension
Measured: One hour prior to scheduled cesarean delivery
Passive leg raise related plethysmography variability index change and correlation with presence of phenylephrine infusion resistant hypotension
Measured: One hour prior to scheduled cesarean delivery
Secondary outcomes (8)
Baseline plethysmography variability index, plethysmography index and systemic vascular resistance values and correlation with presence of phenylephrine infusion resistant hypotension
Measured: From administration of spinal anesthetic to delivery of infant
Passive leg raise related plethysmography variability index and cardiac output change and correlation with severe phenylephrine resistant hypotension
Defined as requirement of 3 or more rescue bolus doses of vasopressor/anticholinergic according to intervention protocol
Measured: One hour prior to scheduled cesarean delivery
Passive leg raise related plethysmography variability index and cardiac output change and correlation with hypotension associated with bradycardia
Measured: One hour prior to scheduled cesarean delivery
Presence of phenylephrine infusion associated side effects
Hypertension or normotensive bradycardia associated with phenylephrine infusion use
Measured: From administration of spinal anesthetic to delivery of infant
Presence of recurrent (3 or more) episodes of phenylephrine infusion associated side effects
Measured: From administration of spinal anesthetic to delivery of infant
Maternal cardiac output and systemic vascular resistance changes following spinal anesthesia
Measured: From administration of spinal anesthesia to delivery of infant
Umbilical cord gases
Measured: At delivery of infant
Apgar scores at 1 and 5 minutes
Measured: At delivery of infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vit Gunka, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279889
- Sponsor's protocol ID
- H10-03231
- Status last verified
- Feb 2012
- First submitted
- 18 Jan 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Hypotension Resistant to Phenylephrine (PE) Infusion in Elective Cesarean Delivery (CD)
- ClinicalTrials.gov ID
- NCT01279889
- Acronym / sponsor ID
- H10-03231
- Conditions
- Hypotension
- Keywords
- hypotension, cesarean delivery, cardiac output, blood pressure, plethysmography variability index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify women at risk of low blood pressure (hypotension) after the usual cesarean anesthetic - a spinal anesthetic. Hypotension may be caused by dehydration. We believe we can predict who will get hypotension by using two anesthesia monitors together with a passive leg raise (PLR) (legs elevated after a period spent reclining). The PLR will cause a shift of blood from the legs to the heart, and the monitors will detect the heart's response to tell if a subject is dehydrated. We want to see if these dehydration tests can also predict hypotension after a spinal anesthetic.
Detailed description
We aim to predict the development of spinal anesthesia related hypotension in subjects already receiving a prophylactic infusion of phenylephrine (PE) who are having a cesarean delivery (CD). Hypotension arising in this fashion may signify that a subject is actually relatively fluid-deplete, and might benefit from intravenous (IV) fluid replacement. We will observe the association between hypotension and results of pre-anesthesia tests with two non-invasive monitors used in conjunction with a dynamic cardiovascular fluid challenge (by using a passive leg raise (PLR) maneuver). The use of any therapeutic intervention such as a fluid infusion would be the object of a subsequent study.
We propose that a minority of parturients present for elective CD being relatively fluid deplete. It is our hypothesis that the characteristics of passive leg raise (PLR) induced changes in the plethysmography variability index (PVI generated by the Masimo Radical 7™) and cardiac output (CO as derived from the Non Invasive Cardiac Output Monitor (NICOM) produced by Cheetah Medical™) will identify these subjects and that without large volume fluid administration they are likely to develop hypotension despite the use of a prophylactic PE infusion
Justification: Hypotension is the most common cause of spinal anesthesia related morbidity in cesarean delivery. Hypotension is very common and without treatment can affect over 80% of women. The mechanism is usually twofold: Firstly preload to the right ventricle (RV) is reduced as a result of venodilation from spinal sympathetic blockade. Unfortunately attempting to improve preload by infusion of IV fluid alone doesn't make much difference to the rates of hypotension (only 16% reduction in one large study). The second mechanism results from afterload reduction through arterial vasodilation which directly causes a reduction in blood pressure (BP). The treatment for this is most commonly a PE infusion, and when used this makes a significant difference reducing rates by over 50%. Unfortunately again there are a few who don't seem to respond (the residual of hypotension remains about 30%). Increasing the doses of PE only increases the rate of side effects, without affecting hypotension rates. However, giving both fluid and a PE infusion does seem to prevent hypotension in almost all subjects, suggesting that those who were resistant to PE alone actually did need some fluid. These subjects however are the exception not the rule, and giving fluid to these relatively "fluid deplete" as well as the rest may result in an increase in fluid related side effects. We believe that fluid therapy could be tailored better if we could identify which subjects are actually fluid deplete in the first instance.
Testing to predict fluid responsiveness has been studied in the intensive care unit (ICU) but not in obstetric subjects. Using a PLR increases the return of blood to the right ventricle (RV). In a fluid deplete individual this significantly improves venous return such that CO changes dramatically. In a well hydrated individual venous return is already adequate so the change in CO is less. The NICOM will directly detect the CO change induced by a PLR. The Masimo detects variations in the pulse oximetry plethysmograph trace that result from subtle variations in the cardiac output caused by changes in the intrathoracic pressure from breathing. Intrathoracic pressure increases during expiration in a spontaneously breathing subject and causes a reduction in venous return to the RV which causes a subsequent fall in CO. The variation in the plethysmography signal with respiration is displayed as a percentage index of the baseline signal strength which correlates with how much venous return to the RV is affected by respiration. If a subject's preload is low the plethysmography variability index (PVI) will be high from the dramatic fluctuation in CO with changes in intrathoracic pressure. Unfortunately with spontaneously breathing subjects this value is not consistent enough between individuals for PVI itself to give an accurate indication of fluid volume state. However changes induced in the PVI within an individual subject from a challenge such as fluid infusion or a PLR appear to be better at indicating fluid responsiveness.
We plan to use both the NICOM and the Masimo in conjunction with a PLR to assess fluid state (deplete or otherwise) preoperatively. We will then observe whether or not the pre-anesthesia testing correlates with development of PE infusion resistant hypotension during the routine spinal anesthetic.
The primary objective of this study is to correlate the results of pre-anesthesia testing with actual development of PE infusion resistant hypotension. Secondary outcomes are discussed in statistical analysis below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean Delivery | – | –Healthy pregnant women having an elective cesarean delivery |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women who are admitted to the hospital for a scheduled elective cesarean delivery
Key inclusion criteria (4 listed)
- Height less than 150cm or greater than 180cm
- Body Mass Index (BMI) greater than 40kg/m2: obesity makes accurate non-invasive blood pressure (BP) measurement difficult. It may also affect speed of onset and height of subarachnoid block due to increased epidural venous plexus engorgement and thecal sac compression resulting in more marked hypotension.
- Pregnancy induced hypertension (BP after 20wk greater than 140/90 with proteinuria)
- High risk of hemorrhage - where fluid volume expansion is planned prior to delivery (e.g. placenta previa, placenta accreta)
Key exclusion criteria (2 listed)
- Starting BP is less than 100 systolic: as the lower limit for intervention defined in this study is 90sys which will likely be within the error of the BP measurement device
- There is a prolonged (more than 2 hour) wait between testing and spinal insertion: as patients may become more dehydrated affecting hypotension rates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Passive leg raise related cardiac output change and correlation with presence of phenylephrine infusion resistant hypotension
Time frame: One hour prior to scheduled cesarean delivery
Passive leg raise related plethysmography variability index change and correlation with presence of phenylephrine infusion resistant hypotension
Time frame: One hour prior to scheduled cesarean delivery
8 secondary outcomes
Baseline plethysmography variability index, plethysmography index and systemic vascular resistance values and correlation with presence of phenylephrine infusion resistant hypotension
Time frame: From administration of spinal anesthetic to delivery of infant
Passive leg raise related plethysmography variability index and cardiac output change and correlation with severe phenylephrine resistant hypotension
Time frame: One hour prior to scheduled cesarean delivery
Passive leg raise related plethysmography variability index and cardiac output change and correlation with hypotension associated with bradycardia
Time frame: One hour prior to scheduled cesarean delivery
Presence of phenylephrine infusion associated side effects
Time frame: From administration of spinal anesthetic to delivery of infant
Presence of recurrent (3 or more) episodes of phenylephrine infusion associated side effects
Time frame: From administration of spinal anesthetic to delivery of infant
Maternal cardiac output and systemic vascular resistance changes following spinal anesthesia
Time frame: From administration of spinal anesthesia to delivery of infant
Umbilical cord gases
Time frame: At delivery of infant
Apgar scores at 1 and 5 minutes
Time frame: At delivery of infant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vit Gunka, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive leg raise related cardiac output change and correlation with presence of phenylephrine infusion resistant hypotension (time frame: One hour prior to scheduled cesarean delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.