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Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography

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ClinicalTrials.gov Identifier: NCT02471924
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Trans thoraciq cardiac ultrasonography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
Actual Study Start Date : June 17, 2015
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Trans thoraciq cardiac ultrasonography
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
Other: Trans thoraciq cardiac ultrasonography
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 Measures :
  1. 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



Secondary Outcome Measures :
  1. Estimate if ΔITVAo is linked to an increase in vasoactiv drugs [ Time Frame: 1 year ]
  2. Estimate if ΔITVAo is linked to fœtal suffering (low acido basic statues in blood section and low APGAR score) [ Time Frame: 1 year ]
  3. Estimate if other echographic measures are linked to hypotension after spinal anesthesia [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471924


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Carole BECHIS, MD Assistance Publique Hopitaux De Marseille
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02471924    
Other Study ID Numbers: 2015-13
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Keywords provided by Assistance Publique Hopitaux De Marseille:
Pregnant women
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases