Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Trans thoraciq cardiac ultrasonography
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Pregnant women
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Trans thoraciq cardiac ultrasonography
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Estimate if ΔITVAo is linked to an increase in vasoactiv drugs
Estimate if ΔITVAo is linked to fœtal suffering (low acido basic statues in blood section and low APGAR score)
Estimate if other echographic measures are linked to hypotension after spinal anesthesia
Full Information
NCT ID
NCT02471924
First Posted
June 2, 2015
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02471924
Brief Title
Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
Official Title
Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 17, 2015 (Actual)
Primary Completion Date
February 20, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Pregnant women
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trans thoraciq cardiac ultrasonography
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Trans thoraciq cardiac ultrasonography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Establish a diagnosis power of the ΔITVAo measured with cardiac ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean.
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Estimate if ΔITVAo is linked to an increase in vasoactiv drugs
Time Frame
1 year
Title
Estimate if ΔITVAo is linked to fœtal suffering (low acido basic statues in blood section and low APGAR score)
Time Frame
1 year
Title
Estimate if other echographic measures are linked to hypotension after spinal anesthesia
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole BECHIS, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28986931
Citation
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.
Results Reference
derived
Learn more about this trial
Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
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