Spinal Induced HypotensionNCT01967914
PVI for Prediction of Spinal Induced Hypotension
An observational study of Spinal Induced Hypotension, run by Duke University at 1 site in United States.
Trial summary
The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Spinal Induced Hypotension
- What is being tested?
- PVI
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2015
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing cesarean delivery under spinal anesthesia
Who may be able to join
- English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
- Scheduled or unscheduled cesarean delivery under spinal anesthesia
- Height: 5 feet-5 feet 11 in.
Who cannot join
- Laboring women needing an emergency cesarean delivery
- Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
- Severe Cardiac disease in pregnancy with marked functional limitations
- Diabetes type I
- Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- Inclusion in another anesthetic study involving drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?
The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery
- Conditions
- Spinal Induced Hypotension
- Being tested
- PVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIOther
Measurement of PVI (plethysmography variability index)
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing cesarean delivery under spinal anesthesia | Not described Receives: Other: PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between baseline PVI and change in SBP from baseline.
Correlation between baseline PVI and change in SBP from baseline.
Measured: Intraoperative (approximately 2 hours)
Secondary outcomes (5)
Correlation between plethysmography variability index (PVI) change in response to passive leg raising (PLR) and change in SBP and pulse rate (PR) from baseline, and need for vasopressors
Correlation between PVI change in response to PLR and change in SBP and pulse rate (PR) from baseline, and need for vasopressors
Measured: Intraoperative (approximately 2 hours)
Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors.
Measured: Intraoperative (approximately 2 hours)
Correlation between baseline PVI and need for vasopressors.
Measured: Intraoperative (approximately 2 hours)
Correlation between baseline PVI and change in SBP and PR from baseline.
Measured: Intraoperative (approximately 2 hours)
Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors
Measured: Intraoperative (approximately 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf S Habib, MB, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967914
- Sponsor's protocol ID
- Pro00046443
- Status last verified
- Jun 2015
- First submitted
- 17 Oct 2013
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?
- ClinicalTrials.gov ID
- NCT01967914
- Acronym / sponsor ID
- Pro00046443
- Conditions
- Spinal Induced Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Oct 2013 (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.
The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing cesarean delivery under spinal anesthesia | – | Other: PVI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing cesarean delivery under spinal anesthesia
Key inclusion criteria (3 listed)
- English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
- Scheduled or unscheduled cesarean delivery under spinal anesthesia
- Height: 5 feet-5 feet 11 in.
Key exclusion criteria (6 listed)
- Laboring women needing an emergency cesarean delivery
- Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
- Severe Cardiac disease in pregnancy with marked functional limitations
- Diabetes type I
- Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVIMeasurement of PVI (plethysmography variability index) | Other | Women undergoing cesarean delivery under spinal anesthesia |
Primary outcome
Correlation between baseline PVI and change in SBP from baseline.
Time frame: Intraoperative (approximately 2 hours)
Correlation between baseline PVI and change in SBP from baseline.
5 secondary outcomes
Correlation between plethysmography variability index (PVI) change in response to passive leg raising (PLR) and change in SBP and pulse rate (PR) from baseline, and need for vasopressors
Time frame: Intraoperative (approximately 2 hours)
Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors.
Time frame: Intraoperative (approximately 2 hours)
Correlation between baseline PVI and need for vasopressors.
Time frame: Intraoperative (approximately 2 hours)
Correlation between baseline PVI and change in SBP and PR from baseline.
Time frame: Intraoperative (approximately 2 hours)
Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors
Time frame: Intraoperative (approximately 2 hours)
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 17 Jun 2015.
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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.
Ashraf S Habib, MB principal investigator
Duke University
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 Spinal Induced Hypotension, run by Duke University at 1 site in United States.
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 3 inclusion and 6 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 17 Jun 2015. 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 United States. 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?
Correlation between baseline PVI and change in SBP from baseline. (time frame: Intraoperative (approximately 2 hours)). 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 17 Jun 2015.