Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
|ClinicalTrials.gov Identifier: NCT02471924|
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : July 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Other: Trans thoraciq cardiac ultrasonography||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471924
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Principal Investigator:||Carole BECHIS, MD||Assistance Publique Hopitaux De Marseille|