PregnancyNCT02471924
Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
A study testing Trans thoraciq cardiac ultrasonography in people with Pregnancy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale and maternal suffering. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Trans thoraciq cardiac ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2015to 10 Oct 2017
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Included patient are all women having a spinal or spinal-epidural anesthesia for elective caesarean section. All patients are more 18 years old and more 37 weeks pregnancy.
- Physical statut score (ASA):1 or 2
Who cannot join
- Woman presenting a contraindication to the spinal epidural anesthesia : constitutional or acquired disorder of the haemostasis
- allergy in the local anesthetics,
- infectious context (hypertherm > 38.5 ° C)
- cardiac, right or left Insufficiency
- eclamptic toxemia
Trial locations and contacts
1 site in 1 country.
About this study
Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale and maternal suffering. It would be interesting to have a tool that could detect patient who are at risk to have hypotension.This study consist in measuring variations of under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output by Trans thoraciq echography.
Read the detailed description
Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools (fluid challenge and vasoactives drugs). Hypotension is responsible of foetale and maternal suffering. Fluid challenge is able to upgrade cardiac output for some patient, for some other it is unusefull or it can deteriorate it. Actually fluid challenge is not individualized. It would be interesting to have a tool that could detect patient who are at risk to have hypotension.
Trans thoraciq echography is an easy non invading tool. Dynamic criteria which is recognized for predicting vascular filling , with spontaneus breathing, is the passive leg rising (PLR). PLR mime à vascular filling of 500 ml. Modification of this cardiac outpout is measured whith the echocardiograph. This consist in measuring variations of under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output.
- Conditions
- Pregnancy
- Being tested
- Trans thoraciq cardiac ultrasonography
- Keywords
- Pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans thoraciq cardiac ultrasonographyOther
Establish a diagnosis power of the ΔITVAo ( aortic velocity peak )measured with cardiac Trans thoraciq ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean. Every patients participate for 30 minutes (time to perform the echography). Outside echographic evaluation, medical taking of participating patients will be exactly the same than what is done for all elective caesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Trans thoraciq cardiac ultrasonography | Other | Trans thoraciq cardiac ultrasonography wil be perforfomed for pregnant women having a spinal or spinal-epidural anesthesia for elective caesarean section. All patients are more 18 years old and more 37 weeks pregnancy Receives: Other: Trans thoraciq cardiac ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a diagnosis power of the ΔITVAo measured with cardiac ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean.
ITVAo corresponds to the variation of complete time speed under aortic between the measure position half seat and the measure of the ITVAo during the test of rise of passive leg.
ITVAo is a reflection of the variation of the volume of systolic ejection. The variation of the volume of systolic ejection led during the test of rise of passive leg, measured in cardiac ultrasound , predicts the answer to the vascular filling at patients of resuscitation
The definition retained for the low blood pressure is a fall of 20 % of the mean arterial blood pressure of base in the first 15 minutes which follow the spinal anesthesia. The basic value of the mean arterial blood pressure is defined as the average of 3 mean arterial blood pressure measures in 3 minutes apart in dorsal decubitus before the practice of the spinal anesthesia
Measured: 1 year
Secondary outcomes (3)
Estimate if ΔITVAo is linked to an increase in vasoactiv drugs
Measured: 1 year
Estimate if ΔITVAo is linked to fœtal suffering (low acido basic statues in blood section and low APGAR score)
Measured: 1 year
Estimate if other echographic measures are linked to hypotension after spinal anesthesia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start17 Jun 2015
- Primary completion20 Feb 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole BECHIS, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471924
- Sponsor's protocol ID
- 2015-13
- Status last verified
- Apr 2023
- First submitted
- 2 Jun 2015
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Zieleskiewicz L, Noel A, Duclos G, Haddam M, Delmas A, Bechis C, Loundou A, Blanc J, Mignon A, Bouvet L, Einav S, Bourgoin A, Leone M. Can point-of-care ultrasound predict spinal hypotension during caesarean section? A prospective observational study. Anaesthesia. 2018 Jan;73(1):15-22. doi: 10.1111/anae.14063. Epub 2017 Oct 7.
PubMed 28986931
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
- ClinicalTrials.gov ID
- NCT02471924
- Acronym / sponsor ID
- 2015-13
- Conditions
- Pregnancy
- Keywords
- Pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Jun 2015 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 15 Jun 2015 (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.
Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale and maternal suffering. It would be interesting to have a tool that could detect patient who are at risk to have hypotension.This study consist in measuring variations of under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output by Trans thoraciq echography.
Detailed description
Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools (fluid challenge and vasoactives drugs). Hypotension is responsible of foetale and maternal suffering. Fluid challenge is able to upgrade cardiac output for some patient, for some other it is unusefull or it can deteriorate it. Actually fluid challenge is not individualized. It would be interesting to have a tool that could detect patient who are at risk to have hypotension.
Trans thoraciq echography is an easy non invading tool. Dynamic criteria which is recognized for predicting vascular filling , with spontaneus breathing, is the passive leg rising (PLR). PLR mime à vascular filling of 500 ml. Modification of this cardiac outpout is measured whith the echocardiograph. This consist in measuring variations of under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans thoraciq cardiac ultrasonography | Other | Other: Trans thoraciq cardiac ultrasonographyTrans thoraciq cardiac ultrasonography wil be perforfomed for pregnant women having a spinal or spinal-epidural anesthesia for elective caesarean section. All patients are more 18 years old and more 37 weeks pregnancy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Included patient are all women having a spinal or spinal-epidural anesthesia for elective caesarean section. All patients are more 18 years old and more 37 weeks pregnancy.
- Physical statut score (ASA):1 or 2
Key exclusion criteria (5 listed)
- Woman presenting a contraindication to the spinal epidural anesthesia : constitutional or acquired disorder of the haemostasis
- allergy in the local anesthetics,
- infectious context (hypertherm > 38.5 ° C)
- eclamptic toxemia
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 |
|---|---|---|
| Trans thoraciq cardiac ultrasonographyEstablish a diagnosis power of the ΔITVAo ( aortic velocity peak )measured with cardiac Trans thoraciq ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean. Every patients participate for 30 minutes (time to perform the echography). Outside echographic evaluation, medical taking of participating patients will be exactly the same than what is done for all elective caesarean section. | Other | Trans thoraciq cardiac ultrasonography |
Primary outcome
Establish a diagnosis power of the ΔITVAo measured with cardiac ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean.
Time frame: 1 year
ITVAo corresponds to the variation of complete time speed under aortic between the measure position half seat and the measure of the ITVAo during the test of rise of passive leg. ITVAo is a reflection of the variation of the volume of systolic ejection. The variation of the volume of systolic ejection led during the test of rise of passive leg, measured in cardiac ultrasound , predicts the answer to the vascular filling at patients of resuscitation The definition retained for the low blood pressure is a fall of 20 % of the mean arterial blood pressure of base in the first 15 minutes which follow the spinal anesthesia. The basic value of the mean arterial blood pressure is defined as the average of 3 mean arterial blood pressure measures in 3 minutes apart in dorsal decubitus before the practice of the spinal anesthesia
3 secondary outcomes
Estimate if ΔITVAo is linked to an increase in vasoactiv drugs
Time frame: 1 year
Estimate if ΔITVAo is linked to fœtal suffering (low acido basic statues in blood section and low APGAR score)
Time frame: 1 year
Estimate if other echographic measures are linked to hypotension after spinal anesthesia
Time frame: 1 year
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 21 Apr 2023.
- Derived from this study: PubMed 28986931Zieleskiewicz L, Noel A, Duclos G, Haddam M, Delmas A, Bechis C, Loundou A, Blanc J, Mignon A, Bouvet L, Einav S, Bourgoin A, Leone M. Can point-of-care ultrasound predict spinal hypotension during caesarean section? A prospective observational study. Anaesthesia. 2018 Jan;73(1):15-22. doi: 10.1111/anae.14063. Epub 2017 Oct 7.
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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.
Carole BECHIS, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans thoraciq cardiac ultrasonography in people with Pregnancy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 inclusion and 5 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 21 Apr 2023. 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 France. 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?
Establish a diagnosis power of the ΔITVAo measured with cardiac ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471924, which also lists 1 linked publication.
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 21 Apr 2023.